BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 11852680 · Received May 19, 2021

    Report

    Report Number
    2939274-2021-02437
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 22, 2021
    Report Date
    April 22, 2021
    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
    UT
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H6: PART: 03.010.523; LOT: L200078; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: FEBRUARY 7, 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE DRIVING CAP/THREADED (PART #: 03.010.523, LOT #: L200078) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, THE THREADED TIP OF THE DEVICE HAS BROKEN OFF. BOTH THE BROKEN PIECE AND THE DEVICE WERE RETURNED. NO OTHER DEFECT WAS OBSERVED. THE DEVICE HAD SURFACE SCRATCHES ALONG THE SHAFT AND SEVERAL DENTS ON THE TOP OF THE PROXIMAL HEAD FROM HAMMER BLOWS. THESE COSMETIC ISSUES ARE CONSISTENT WITH NORMAL WEAR. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: SPECIFIED DIMENSIONS: THREAD MAJOR DIAMETER M8; TIP SHAFT OD. MEASURED DIMENSIONS: THREAD MAJOR DIAMETER M8: CONFORMING. TIP SHAFT OD = CONFORMING. DEVICE USED ¿ HAND MICROMETER. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE THREADED TIP HAS BROKEN OFF. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS A PIE HAS BEEN LAUNCHED TO ADDRESS THE IDENTIFIED ISSUE. THE NEED FOR FURTHER CORRECTIVE/PREVENTIVE ACTION WILL BE ASSESSED WITHIN THE PIE. FURTHER INVESTIGATION WILL NOT BE CONDUCTED IN THIS COMPLAINT AS IT WILL BE ADDRESSED WITHIN THE PIE. A SUSTAINING ENGINEERING TICKET AS ALSO BEEN OPENED TO ADDRESS THIS 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

    PRODUCT COMPLAINT # (B)(4). DEVICE RETURNED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION.AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, DURING FEMORAL RECON NAIL (FRN) INSERTION, THE THREADS ON THE DRIVING CAP BROKE OFF INSIDE THE INSERTION HANDLE. THE NAIL WAS NOT FULLY INSERTED, SO THE SURGEON HAD TO USE A BONE TAMP TO HELP SEAT THE NAIL PROPERLY. THREADS OF THE DRIVING CAP ARE RETAINED IN THE INSERTION HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FIFTEEN MINUTES OF SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746440 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 L200078 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1 RADIOLUCENT INSERTION HANDLE FRN| UNK - NAILS