BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 7234158 · Received February 1, 2018

    Report

    Report Number
    2939274-2018-50467
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Report Date
    January 11, 2018
    Manufacturer
    WRIGHTS LANE: SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982196347
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: LOT NUMBER, UDI. DATE RETURNED TO MANUFACTURER. DATE OF MANUFACTURE. DHR REVIEW WAS COMPLETED. DEVICE HISTORY RECORD (DHR) REVIEW: PART#: 357.411, LOT#: 3328R16. MANUFACTURED BY SUPPLIER AEROMED INC. MANUFACTURING DATE: 16-MARCH-2010. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. THE 357.411 INSERTION HANDLE IS A REUSABLE INSTRUMENT ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM TO AID IN FEMORAL NAIL INSERTION. THE RETURNED 8+ YEAR OLD INSERTION HANDLE WAS RECEIVED AT CUSTOMER QUALITY (CQ) WITH SIGNIFICANT POST MANUFACTURING DAMAGE. THE DEVICE HAS SEVERAL DENTS AND SCRATCHES INCLUDING HAMMER MARKS ON THE "DO NOT STRIKE" ETCH. THEREFORE THIS COMPLAINT IS CONFIRMED FOR DAMAGE. HOWEVER THE COMPLAINT FOR MISALIGNMENT WAS NOT ABLE TO BE CONFIRMED OR REPLICATED VIA FUNCTIONAL TEST BECAUSE THE OTHER DEVICES USED IN THE CONSTRUCT WERE NOT RETURNED. THE DAMAGE IN THE HOLES COULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION. A DIMENSIONAL INSPECTION OF FEATURES RELEVANT TO THIS COMPLAINT COULD NOT BE OBTAINED AT CQ DUE TO THE POST MANUFACTURING DAMAGE. DRAWINGS MANUFACTURED THROUGH CURRENT WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MATERIAL AND RELEVANT MATERIAL PROPERTIES WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. A DEFINITIVE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. IT IS LIKELY THAT THE FORMATION OF DENTS AND HAMMER MARKS WERE CAUSED BY MISPLACED HAMMER STRIKES AND ROUGH HANDLING OVER THE DEVICE'S 8+ YEAR SERVICE LIFE WHICH HAVE LED TO THIS COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    (B)(6) REPORTED AS FOLLOW: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE SURGERY, INSERTION HANDLE FOR TROCHANTERIC FIXATION NAIL WAS BENT OR DAMAGED AND DID NOT ALLOW THE AIMING ARM TO ALIGN WITH THE HOLE IN THE NAIL. THERE WERE NO FRAGMENTS GENERATED, AND THERE ARE NO MISSING PIECES. THE SURGERY WAS COMPLETED USING THE DEVICE, WITH NO REPORTED PATIENT HARM. CONCOMITANT DEVICE REPORTED: TFN AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78078 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS GUIDE FZX WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 3328R16 10886982196347

    Patients

    Seq Age Sex Outcome Treatment
    1