BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 8696412 · Received June 13, 2019

    Report

    Report Number
    2939274-2019-58633
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Report Date
    May 15, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982069351
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, H6: PART: 03.010.523; LOT: L811199; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: JUNE 08, 2018 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION THE DRIVING CAP/THREADED WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). A VISUAL INSPECTION WAS PERFORMED. THE THREADED TIP OF THE DRIVING CAP SHAFT WAS OBSERVED TO BE COMPLETELY BROKEN OFF AND EMBEDDED IN THE RETURNED INSERTION HANDLE (PART: 03.033.001, LOT: L971715). NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. THE INSERTION HANDLE WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. DIMENSIONAL INSPECTION DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE OF THE DISTAL THREADS AND TIP (RELEVANT FEATURES). DOCUMENT/SPECIFICATION REVIEW CONNECTOR FOR INSERTION HANDLE ¿ MANUFACTURE AND CURRENT REVISION INVESTIGATION CONCLUSION THE COMPLAINT IS CONFIRMED FOR THE DRIVING CAP/THREADED AS THE THREADED TIP OF THE SHAFT WAS OBSERVED TO BE COMPLETELY BROKEN OFF AND EMBEDDED IN THE RETURNED INSERTION HANDLE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES AND/OR EXCESSIVE OFF-AXIS STRIKING. 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

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE DEVICE WAS 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 ON AN UNKNOWN DATE, WHEN PUTTING THE SET TOGETHER, THE TIP OF DRIVING CAP/THREADED HAS BROKEN OFF INTO THE RADIOLUCENT INSERTION HANDLE FEMORAL RECON NAILS (FRN). THE PIECE COME APART OF THE FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL. THERE WAS NO PATIENT INVOLVEMENT CONCOMITANT DEVICE REPORTED: RADIOLUCENT INSERTION HANDLE FRN (PART # 03.033.001, LOT # UNKNOWN, QUANTITY # 1) & FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL (PART # 351.16, LOT #: UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489884 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 L811199 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1