BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT INSERTION HANDLE FRN

    MDR report key: 11791525 · Received May 7, 2021

    Report

    Report Number
    2939274-2021-02258
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Report Date
    April 12, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982271051
    PMA / PMN Number
    K172157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H3, H4, H6: PART: 03.033.001, LOT: L971715, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 15 NOV 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE RADIOLUCENT INSERTION HANDLE FRN (P/N: 03.033.001, LOT #: L971715) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, THE BROKEN TIP OF THE MATING DRIVING CAP WAS RETAINED IN THE THREADED PORTION OF THE INSERTION HANDLE BUT COULD BE FULLY REMOVED. THE DEVICE SHOWS ONLY LIGHT SURFACE WEAR CONSISTENT WITH USE AND WHICH WOULD NOT IMPACT THE FUNCTIONALITY. DEVICE FAILURE/DEFECT IDENTIFIED? NO, THE RECEIVED CONDITION DOES NOT AGREE WITH THE COMPLAINT DESCRIPTION AND IS NOT CONFIRMED AS NO FRACTURES/BREAKS WERE OBSERVED ON THE RETURNED DEVICE. THE MATING DEVICE WAS NOTED TO BE BROKEN. CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED AS NO DAMAGE WERE OBSERVED ON THE RADIOLUCENT INSERTION HANDLE FRN (P/N: 03.033.001, LOT #: L971715). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE WERE IDENTIFIED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    IT WAS REPORTED THAT, BROKEN RADIOLUCENT INSERTION HANDLE FRN (FEMORAL RECON NAIL SYSTEM) AND DRIVING CAP/THREADED ATTACHMENT WAS FOUND AND DISASSEMBLED DOWN IN THE STERILE PROCESSING DEPARTMENT. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FRN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688833 RADIOLUCENT INSERTION HANDLE FRN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.033.001 L971715 10886982271051

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVING CAP/THREADED| DRIVING CAP/THREADED