BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW

    MDR report key: 5839486 · Received August 2, 2016

    Report

    Report Number
    0009613350-2016-01096
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 8, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL INFORMATION WAS RECEIVED ON AUGUST 17, 2016. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION HAS BEEN INITIATED. TWO PICTURES WERE RECEIVED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORD WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    TREND ANALYSIS: NO TREND IDENTIFIED. THE DEVICE HISTORY RECORD WERE REVIEWED AND FOUND TO BE CONFORMING. EVENT DESCRIPTION (EVENT DETAILS, PER) EVENT SUMMARY: IT WAS REPORTED THAT DURING A REMOVAL OF A ZNN NAILING SYSTEM THE SURGEON EXPERIENCED THAT THE WINGS OF THE LAG SCREW BEGAN TO TWIST. THE LAG SCREW INSERTER HAD BEEN FIRMLY CONNECTED TO THE LAG SCREW. HE DECIDED NOT TO GO FURTHER WITH THE LAG SCREW INSERTER AND FINALLY REMOVED THE LAG SCREW WITH 00-2490-090-12 CM LAG SCREW EXTRACTION DEVICE. REVIEW OF RECEIVED DATA - THERE WERE 3 X-RAY PICTURES PROVIDED. THE X-RAYS WERE TAKEN DURING THE TIME IN VIVO. THE BREAKAGE/TWIST OF THE LAG SCREW WAS OCCURRED DURING THE REMOVAL - INTRAOPERATIVE. THERE ARE NO X-RAY PICTURES AVAILABLE OF THE INTRAOPERATIVE SURGERY WHERE THE LAG SCREW BREAKAGE CAN BE SEEN. - A SURGICAL REPORT OF IMPLANTATION AND A SURGICAL REPORT OF THE REMOVAL WAS PROVIDED IN FRENCH. THE SURGICAL REPORT OF IMPLANTATION DATED (B)(6) 2015 DESCRIBES THAT A ZNN NAILING SYSTEM WAS IMPLANTED. THE SURGEON TRIED SEVERAL TIMES TO PLACE A CERCLAGE WIRE BUT WAS NOT ABLE TO DO IT AS THE PATIENT WAS VERY MUSCULAR. FINALLY THE WHOLE SYSTEM WAS IMPLANTED AND THE LAG SCREW AS WELL THE SET SCREW WERE PLACED DYNAMIC. -THE SURGICAL REPORT OF THE REMOVAL DATED (B)(6) 2016 DESCRIBES THAT THE SET SCREW WAS REMOVED AND AFTERWARDS THE SURGEON USED THE LAG SCREW INSERTER TO REMOVE THE LAG SCREW. WHILE REMOVING THE LAG SCREW THE SURGEON REALIZED THAT THE LAG SCREW NOTCHES BEGAN TO TWIST. HE DECIDED TO CHANGE THE INSTRUMENT FOR REMOVING. FINALLY, THE SURGEON WAS ABLE TO REMOVE THE LAG SCREW WITH THE LAG SCREW EXTRACTION DEVICE. DEVICES ANALYSIS: - VISUAL EXAMINATION: THE LAG SCREW AND A SET SCREW WERE RETURNED FOR INVESTIGATION. THE VISUAL INVESTIGATION SHOWS THAT THE LAG SCREW TABS WERE CRACKED AND NOT COMPLETELY BROKEN. THE CRACKS ARE LOCATED ON BOTH NOTCHES. ON THE SHAFT AREA OF THE LAG SCREW THERE ARE CIRCULAR MARKS (POLISHED AREAS) VISIBLE. THE RETURNED SET SCREW SHOWS A TIP DEFORMATION. THIS DEFORMATION WAS MOST PROBABLE OCCURRED WITH THE CONNECTION INTO A LAG SCREW GROOVE. - THE REMOVAL OF THE ZNN NAILING SYSTEM WAS DONE AFTER 16 MONTHS WHEREAS A FRACTURE SHOULD BE UNITED WITHIN 6-9 MONTHS. REVIEW OF PRODUCT DOCUMENTATION - THE REMOVAL OF THE LAG SCREW IS DESCRIBED IN THE SURGICAL TECHNIQUE 97-2493-002-00. "TO REMOVE THE LAG SCREW IT IS NOT NECESSARY THAT THE SET SCREW IS COMPLETELY REMOVED. TURN THE SET SCREW TWO TURNS BACKWARDS AND MAKE SURE THAT THE SET SCREW IS STILL ENGAGED IN THE THREADS OF THE NAIL. IT IS RECOMMENDED TO USE THE LAG SCREW CANNULA AS GUIDANCE FOR THE LAG SCREW INSERTER WHILE REMOVING THE LAG SCREW. ASSEMBLE THE LAG SCREW INSERTER THROUGH THE LAG SCREW CANNULA INTO THE LAG SCREW. USE THE COMPRESSION DEVICE TO PUSH THE LAG SCREW CANNULA TO THE BONE. MAKE SURE THE LAG SCREW INSERTER IS FULLY SEATED. HAND TIGHTEN THE LAG SCREW INSERTER WITH THE 3.5MM HEX SCREWDRIVER. IF A SECONDARY OPTION IS NEEDED TO REMOVE THE LAG SCREW, THE CM LAG SCREW EXTRACTION DEVICE CAN BE USED. TO USE THE CM LAG SCREW EXTRACTION DEVICE, ALIGN ITS AXIS WITH THE AXIS OF THE CM LAG SCREW THAT IS BEING EXPLANTED. THE CONICAL THREAD OF THE CM LAG SCREW EXTRACTION DEVICE SHOULD THEN BE ENGAGED AND ROTATED IN A COUNTER-CLOCKWISE MOTION INTO THE EXPOSED LATERAL THREADS OF THE CM LAG SCREW THAT IS BEING EXPLANTED. THE ROTATION DIRECTION IS COUNTER-CLOCKWISE AS THE CM LAG SCREW EXTRACTION DEVICE UTILIZES REVERSE-CUTTING FLUTES TO ENABLE MATING TO THE CM LAG SCREW. WHILE ROTATING, A CONSTANT AXIAL FORCE MUST BE APPLIED TO MAINTAIN THE TOOL DRIVING INTO THE CM LAG SCREW THREAD. WHILE CONTINUING TO ROTATE THE CM LAG SCREW EXTRACTION DEVICE COUNTER-CLOCKWISE, THE CM LAG SCREW THAT IS BEING EXPLANTED WILL UNSEAT FROM THE BONE AND CAN BE REMOVED". CONCLUSION SUMMARY: FOLLOWING ROOT CAUSES CAN BE POSSIBLE FOR THIS ERROR PATTERN: EXCESSIVE BONE INGROWTH ONTO THE LAG SCREW DUE TO LONG IN VIVO TIME OF THE IMPLANT SYSTEM, WHICH MAKES HIGH FORCES NEEDED TO REMOVE THE SCREW IN A REMOVAL CASE. THE REMOVAL OF THE ZNN NAILING SYSTEM WAS DONE AFTER 16 MONTHS WHEREAS A FRACTURE SHOULD BE UNITED WITHIN 6-9 MONTHS. PATHOGENIC BONE DISEASES (E.G. BONE TUMOR) WHICH AFFECT MECHANICAL PROPERTIES OF THE BONE (HARDER/ DENSER BONE SUBSTANCE). AS NO INFORMATION IN THE SURGICAL REPORT WAS PROVIDED ABOUT THE PATIENTS BONE CONDITION, THIS POINT CANNOT BE EXCLUDED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED A CMN FEMORAL NAIL WITH A ZNN, CMN LAG SCREW 10.5 MM, 105 MM ON THE LEFT SIDE ON (B)(6) 2015. THE COMPONENTS WERE EXPLANTED ON (B)(6) 2016. THE FOLLOWING STATEMENT WAS REPORTED: "WHILE THE LAG SCREW INSERTER HAD BEEN FIRMLY CONNECTED TO THE LAG SCREW, WHEN THE SURGEON BEGAN TO REMOVE IT, THE WINGS OF THE LAG SCREW BEGAN TO "TWIST". THE SURGEON DECIDED NOT TO GO FURTHER WITH THE LAG SCREW INSERTER AND FINALLY REMOVED THE LAG SCREW WITH 00-2490-090-12 CM LAG SCREW EXTRACTION DEVICE. NO BROKEN PIECES REMAINED IN THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED A SET SCREW, 8 MM, 21 MM, HEX 3.5 MM ON THE LEFT SIDE . THE FOLLOWING STATEMENT WAS REPORTED: "WHILE THE LAG SCREW INSERTER HAD BEEN FIRMLY CONNECTED TO THE LAG SCREW, WHEN THE SURGEON BEGAN TO REMOVE IT, THE WINGS OF THE LAG SCREW BEGAN TO "TWIST". THE SURGEON DECIDED NOT TO GO FURTHER WITH THE LAG SCREW INSERTER AND FINALLY REMOVED THE LAG SCREW WITH 00-2490-090-12 CM LAG SCREW EXTRACTION DEVICE NO BROKEN PIECES REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492206 ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS, HSB ZIMMER GMBH N/A 2794465

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other