SURGICAL PROCEDURE CNAIL MEDIN NEVA ore Medical1. Description of medical device [CNALs an intramedullary nal for minimal-invasive fiation of itaarticulae caleaneal atures The principle ist stabilize with the nal the our to five main ‘fragments of the fractured calaneus in conjunction with upto seven interloe: king Screws and thus creating angular stable ration The maximum of tality Isachieved by fing the sustentaculr fragment towards the nalwith two inter- locking serens guided bya very precise aiming device “The design of the mals separated ofthe lf leg neated by Land therght leg indicated by “R). The nal length is 65 mm with a diameter of 8 mm. The ral canbe extended an¢ closed by an end eap with izes: O mS am 10 mm, 15 mr 20 mm. ‘The implants are al supplied unsterle and must be sterilized before ope: 2. Indication Invaarticulae fractures ofthe aleaneus according to Sanders according ICAO-ASIF Classfiaten. MEDINas, SURCICALPROCEDURE | CAL | 00 EDative \nning and principle of surgical tech- nique Within the framework of preoperative planning one must vert the appropri- tenes ofthis surgical technique, One of the parameters that must be veri fed isthe length ofthe calcaneus, which must not be shorter than 65 mm. Preoperative rays ofthe lateral, al and dorsoplantar broken calaneus are recommended as wellasa CTscan i two planes eventually shown adtionaly in 30 reconstruction. For knowing the indivigual ohler’s angle 2 comparative IateralXeray ofthe healthy calcaneus shouldbe taken ‘Te underying principle of she operation isthe minimabinvasive fixation of 2 fractured calcaneus with an interlocking nal which introduce by ta ines ‘ons aftr inital anatomic reduction ofthe posterior facet Thisint reductions performed by subtalar artroseopy or alateral3 em long intramaleoanesion “Through this approach the tuberosity fragments reduced tthe sustertacular fragment by help ofa smallrasparorum xing temporarily witha 18/20 mm Kee Then the lateral part ofthe posterior facet fragments reduced towards the medial part of the posterior facet and temporarily fixed with two Kavires (118/20 me below bur parallel to the joint level If theres an adetonal inte mediate joint ragment ile SandersiV the insiée-outinside Kewie technique Should be performed for anatomic joint eduction After restoring the posterior subtalar joint and Bahler* angle, controling the rezuk with fuororcoay expe ‘ally ith Broden’s projection the aiming wire fr the nai dil below the attachment ofthe Aches tendon fowards the cente of the cakaneoeuboid jeint. Controling this Kewire uoroseopically to be aso inthe middle axes of the calcaneus over driling then for introduction ofthe all is done. Te nail is connected before intruction to the aiming device. Fi then withthe help ‘ofthe radiolucent arms ofthe aiming device fst the sustentacular fragment towards the introduced C-Nail by inserting fist a Kowire trough the signed "SUSTENTACULUM” guiding arm into te sustenaculum, Only after Konite posi tioning exactly into the sustentaculum close to the mide facet, controled by ‘uoroscopy, the fst sustentacular interlocking srew is inserted The second sustentacular screw and then consequently the thre lateral and two superior "crens sing the sighed" LATERAL" andSUPERIOR" guiding arms are brought inplace 4. Preparation of instrumentation and implants Prior tothe operation its necessary to checkthe completeness andfunctions- ly fal pats ofthe instrumentation. ‘onthe basic body of the aiming device aiming device armsaresetintoa post ‘onbased on the chosen side of the operated extremity. The aiming device arms ar ued ith fxation screws, which ae tightened reasonably tthe base body with the help of wrench rods ‘The nail is placed in the aiming device grooves, and is firmly fixed using the aiming device sre Prior to use inspection must be performed ofthe position af the aiming device {arms agains the tight ral Inspection is performed fr all seven Males GERI sucica. onoceoure | cat | Ro > ae > MEDIN, 25. Operating technique 5.1. Position of patient ‘The patient isin a lxerl postion with a slightly flexed knee. The involved extremity is suppartee by a soft ylindrial pill fom the medial si, The other extremity is bent in the knee jint to not interfere with using fluores copic equipment 5.2, Drawing of the position of the bones ‘The landmarks ofthe lateral malleolus, calaneus and cuboid are drawn Iate- rallyon the skin 5.3. Incision for mini-open reduction of the posterior joint surface For reduction of the posterior facet a3 em long incision below the tp af the Iateral malleolus in irection othe base ofthe fifth metatarsal bone is marked, ‘Wen making the incision cautions recommenced not to damage the peroneal tendons 5.4, Reduction manoeuvre for restoring Béhler's angle and the posterior joint surface Reduction of the tuberosity fragment towards the sustenacuar ragmentis most often achieve by inserting 36 5 mm cancellous Senanz-serew with handle th rough a stab inesan int the tuberosity or rangue rype fragment by correcting lateral translation, varus or valgus malpesiton or andor plantar ting ofthe tuberosity Sometimesa smallraspartorum sadeivonally needed tobeintrod- ‘ced below the broken posterir fact to mobilize the tuberesty fragment fem Inmpacton int the sutenaclat Fragment Ater tis intalredction manaeure vith keeping the tuberosity fragment towards the sstentaculr fragment with 218/20 mm Kore the redvction of posterior facets performed sing an ele ‘ator orsmallrasparorium, 5.4.1. Temporary fixation using K-wires ‘ter inital emporay ation ofthe reduced tuberosity fragment towards the sustenacular fragment with a Kove the lateral part ofthe reduced posterior facet fragments fixes with two wits (1.8/2.0 mm) tothe medial part ofthe posterior facet, n ease ofa lilocated intermeeiate fragment ofthe postr fr facet (type Sanders IV) the inside-out inside wire fration manoeuvre is recommended. Correctness af the congruency ofthe posterior subtalar jint Isnow checked uorascopealy wth the Broden’s projection MEDINas, C-NAIL SURCICALPROCEDURE | CNAL | R00 END5.4.2. Fixation using cancellous screws Definitve fxation ofthe posterior facet is usually achieved by inserting two separate 40 mm cancellous screws whch substitte and run lke the previous ‘yates below the joint in elrection tothe sustentaculum, lasing due to com- pression any given interfragmentary gap. 5.5, Removal of Schanz-screw, control and/or redu- tion of the calcaneo-cuboidal joint 5.5.1. Removal of the Schanz screw ‘The Schanz-screw with hanle removed ar s00n3¢congruency ofthe subtalar Joints een Muorscop eal orby open arthroscopy. 5.5.2. Control and/or reduction of the calcaneo-cuboidal joint Incase of a2 fracture with a broken calcaneo-cuboial joint ateraland dorsc- plantar uoroscopic projection shoul show an inivctly reduced cuboidal fo- ‘et This intraarticular fracture canbe secured by 1 or2 percutaneousely inserted ‘40 mm cancellous screws cose tothe cleaneo-cuboial joint but positioned ‘note inthe dorsal and plantar height ofthe calcaneus not to hiner the fl lowing insertion ofthe nal. Tincongruence is given an adeitianal small lies approach will help to achieve anatom c reduction before stalizing the cuboicl facet with sews 5.6. Introducing of the nail 5.6.1. Incision For inserting the nal a 10 mm vertical incision under the attachment of the Achilles tendon is mae slightly lateral to the center of the dorsal heel aspect, GER surcica.enoceoune | cA | noo MEDINas.5.6.2. Drilling the guide wire for the nail hole The direction of dling the guide wire is determined by the center ofthe cae eo-cuboida joint. Driling is performed using guide wie trough protective sleeve in which the guide ve is centialzed. The position ofthe gue wit i contol Muorscop ell by lateral ane dorso-plantar projections. 5.63. Drilling the hole for the nail Diling is performed with the cannulated 8 mm ell bit. The soft tissues are protected during eriling by the guide sleeve The depth of dling ends appro imately S mmin frontof the ealeaneo-cuboida in tis possible toread the Grlling depth onthe etter scale atthe level ofthe guide sleeve. After diling the hole, the cuter and guide wie ae extracted, 5.6.4, Introducing of the nail with the attached aiming device “The nai the atached aiming devices introduced no the dled hole Ths Is performed by mild axial pressure and rotational motion of the aiming device wth the nal MEDINas, C-NAIL SURGICALPROCEDURE | CNAL.| Roo ERINAIL ‘he covet rotational postin ofthe nals gen as soon a the fst Kir wth oie (20 mm postioned under Fuororcopic central through the guiing sleeve heh postoned inthe porter ole ofthe: nstentaclun’ name guiding arm exactly nto ‘he sustentaculir Fragment ending close ote mide facet Aer his emporaryKenire faatin the sere ell itis inredced though the guiding leve which postioned ‘through the anterarhoe ofthe “SUSTENTACULUM' guiding rm fra clze tothe bone Ths enabled ater ta incon by using the cana tocar far devitng the sot tissues and allowing firm contac ofthe guiding sleeve tothe bone whi dling and reasring length forthe sre onthe crilitscale Before nzertng the sxrew checkthe poston ofthe cil it by fuoroscpic aval rojecion tebe sure tat the susentacumis Btwel if posting sight theserewis inserted and the inital postoned ve tvough ‘the posterior aiming holes substitutes by screw wth proper engi. pestering is sot eoret tsnecessary to remove he nial used Vor and cect retation athe aiming device tohave atleast 2 crews apimallypastoned the sustentculm, SURGICAL PROCEDURE | NAIL | ROO5.6.6. Introducing the remaining interlocking screws The remaining interlocking screws are then introduced using the “SUPERIOR® guiding arm fr the tuberosity or tongue type fragment. As soon as this is done ‘he fst inserteg Koi en be removed. Atleast the LATERAL” guiding arm of the aiming device is use for xing the anterior process fragment being aware ‘hat there no step leftin the cubodal facet, During introduction ofthe guicing sleeves alays necesary to measure careful the length ofthe needed screw: 0 that they run bicortialy Screws should nt prottude through the second cor {exin order to minimize ietaton of sft se. The screws ae specally designed wth flathead to prevent thir undesired embeding into the bone, Screws are placed on tne scewcrver and introduces tothe dled hol through the guide Sleeve (blue stp) The screw head tsts upon the cartexby gently Ughtening with the screwdriver nthe correct potion af the sleeve esting agains the cortex the sew depthis given by the scale onthe srendriverhandle.Ahand-held screv- verisused exclusively for introducing screws ‘CAVE: When introducing a screw through the middle guiding hole of the “LATERAL” arm ofthe aiming deviceitisnecessary to vsualizeand spread the stab incision witha damp to prevent any damage to the peroneal tendons whl inserting the conical trocar. 5.6.7. Verification of fixation ‘ter introducing al screws the fied calcaneus is checked proofing joint red ‘tion, Bohlers angle aswell as poston and length ofl scews by Nuoroscopic Braden’, ater axial and dorso-plantar projections. 5.46.8, Removing the aiming device “The aiming device i released from the mall by loosening the clamping screw. Release is performedtby using a wrench rod inthe screw head hale 5.6.8. Introducing the end cap ‘an end cap i introduced into the hole atthe end of the nal The end cap Fength (0m; 5 mm; 10 mm; 15 mm; 20 mm) is chosen as long as prelon- gation of the nals needed to end flush withthe dorsal cortex ofthe ca: MEDINas, C-NAIL SURGICALPROCEDURE | CAL | R00 EADC-NAIL 5.7. Final documentation performing fluoroscopic on cray views To document reduction ofthe subtalar and caleaneo-cuboidal joint therestored Bohler’s angle, the poston and length of the nail anda used serews Braden, lateral, axial and dorso-plancar projections are taken by Musroseopie or ay views, feed etal andor printed. 5.8. Completion of operation The wounds ae rinsed wth a suficientquantyofphysiolgial solution. Due tethe minimalivasve procedure Redon drainages svaly not needed The smal subtalar aint approsch may nee a subcutaneus sutre, the stab ne sions ony askin sure Atleast a sel essing» pefabrcted spn ran elastebancageis applied. 5.9. Final notes ~ When using the C-allsetitcannot be usedin combination with various mate tials = Combinasion with implants of other manufacturers mustbe avoided ~ Implants are designed for one-time use only 6. Recommended procedure for extracting the implant Implants may stay permanently inthe caleaneus.fremovelofnalland screwsis indicated t should regularly performed afer 60 12 months after implantation having proofed proper bone healing by taking x1ays or CTscan before. 6.1. Extraction procedure = Loosen endeap = Remove all screws = stract nll wth the foreseen device GEE surcica.enoceoune | cL | noo MEDINas.7. Recommended method of cleaning instrumentation = Remove the arms from the aiming device body ~ Perform mechanical cleaning wth water ane brush Rinse he instruments with pressurized water = Submerge the instruments na lsinfecting solution fr 20o 30 minutes. The recommended disinfection agent i Sekusept. Danger of damaging intru- ments exits ifa diferent olution i applies = Rinse again with pressurized water unt only clean water runs ft Rinsing may be performed ina conventionally supalie pressunzee washer for connecting instruments othe jets = Dy 8, Recommended meth: tion and implants ation of instrumenta- Prior to use itis necessary to thoroughly wash and disinfect the instruments and implants. Steam sterlzation i recommended, The selzationtemperstu remay not exceed 135°C In temperatures in excess af 135°C causes damage tothe plastic pats andthe clor-coding of instruments. Such damaged instr ments may not be permitted for use MEDIN, as SURGICAL PROCEDUI C-NAIL Lcnan [Roo EIDNAIL CALCANEAL NAILS o8mm END CAPS a La RIGHT sst 129784160 Ler sst 129784170 sst 129772210 129772220 129772230 129788880 129788890 Ti 129784163 Ti 129784173 Ti 129772213 129772223, 129772233, 129788883 129788893 ‘SELF-TAPPING CORTICAL BONE SCREWS WITH FLANGED HEAD - HA 3,5 Lie A NOTES: SSt~stalnless steel in accordance withI505832-1 Ti ‘Theimplants are supplied unter GERDII surcica.anoceoune | cA | noo sst 129785651 129785661 129785671 129785681 129785691 129785701 129785711 129785721 129785731 129785741 129785751 129785761 129785771 129785781 129785791 129785801 129785811 129785821 129785831 T 129785654 129785664 129785674 129785684 129785694 129785704 129785714 129785724 129785734 129785744 129785754 129785764 129785774 129785784 129785794 129785804 129785814 129785824 129785834 omm Simm tomm ism 20mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 40mm 42mm 44mm 46mm 48mm 50mm 55mm 60mm 65mm Tomm Fig. Fig. 5 Fig. 10 Fig. 15 Fig. 20 iranlum version, materal TIGA ELI in aecordance with ISO 5852-3 MEDIN, 2C-NAIL INSTRUMENTS FOR C-NAIL 2 15 b= 23 i MEDIN = a DB acrruntenrs FOR CNA 7/7 7 wf wf w/ is INSTRUMENTS Sieve forinstrumenents n 2 3B “4 8 129.69 5980 129694910 129696340 129696670 129696350 129.69 6300 129.69 5800 129695810 129695840 129695830 129786750 129.69 6680 129696291 129695851 129696100 ‘Aiming device C-Nail Sleeve 0 8/6,1 Sleeve 0 6,1/2 Sleeve @ 6,1/2,7 Trocar B 6mm Screwidiver; hexagonal 25 Drilling sleeve Sleeve for K-wire; @ 8/2,5 Gauge Guide K-wire 82,5 x 200mm Kewire with olive @ 2% 300 mm Dril 92,7230 Dril 2 8/2,5%240 Wrench rod MEDINas, SET OF INSTRUMENTS FOR. 139090545 ‘540240 x 70 mm sieve with instruments, without implants NAIL STAND FOR SCREWS FOR C-NAIL 129697180 160 x 125 x 81 mm without implants SURGICALPROCEDURE | CNAL | R00 EENNAIL Notes: N00 [ished in any form without approval of MEDIN, as. The product design may differ from those depicted in these illustrations atthe date of issue. Adjustments, made from the reason of fur- ‘he devlopmens tna preter reeset Pangan pega eo ae ese 5 GREE sucica. enoceoure | cat | Ro eon as?NAIL shed any form without approval of MEDIN, as, The product design may dif fom those depicted in these listations tthe date af se. Adjustments made from the reason af fu- ‘her developments oftechneal parameter reserve Pring atl ypostaphicl ers are reserve N00 sb pan GEIB suncica. onoceoune | cA | noo eonvas 2Lavend DLV Nena