BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 10945708 · Received December 4, 2020

    Report

    Report Number
    2939274-2020-05448
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 8, 2020
    Report Date
    November 9, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982069351
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 03.010.523, LOT L812338: MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: JUNE 29, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DISTAL TIP OF THE DEVICE WAS BROKEN, AND THE BROKEN FRAGMENT WAS STUCK INSIDE THE RECEIVED INSERTION HANDLE. THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION SHOWED THE RELEVANT DIMENSIONS WERE CONFORMING. BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. THE COMPLAINT CONDITION IS CONFIRMED FOR THE DRIVING CAP/THREADED (P/N: 03.010.523, LOT #: L812338). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. 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 DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 DURING A FEMORAL SHAFT FRACTURE PROCEDURE ON (B)(6) 2020, THE DRIVING CAP WITH THREADS BROKE OFF IN THE INSERTION HANDLE WHILE STRIKING THE REPORTED DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FIFTEEN (15) MINUTES SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: RADIOLUCENT INSERTION HANDLE (PART # 03.033.001, LOT # L849563, QUANTITY 1), UNKNOWN AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411246 DRIVING CAP/THREADED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 L812338 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR RADIOLUCENT INSERTION HANDLE FRN| UNK - GUIDES/SLEEVES/AIMING: AIMING ARM| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA| UNK - NAILS: FEMORAL| RADIOLUCENT INSERTION HANDLE FRN| UNK - GUIDES/SLEEVES/AIMING: AIMING ARM| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA| UNK - NAILS: FEMORAL