BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 9751013 · Received February 25, 2020

    Report

    Report Number
    2939274-2020-01043
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Report Date
    February 4, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXC
    UDI-DI
    10705034720128
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 # 03.641.004, SYNTHES LOT # H130932-12, SUPPLIER LOT # H130932-12, RELEASE TO WAREHOUSE DATE: 19 OCT 2016, SUPPLIER: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE DEVICE FAILED IN CALIBRATION. THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED HIGH. TORQUE TEST HIGH IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. FLOW: POWER TOOLS/CALIBRATION. VISUAL INSPECTION: THE SOCKET WRENCH FOR VEPTR NUT (PART # 03.641.004, LOT # H130932-12, MFG # 19-OCT-2016) WAS RECEIVED AT US CUSTOMER QUALITY (CQ) WITH NO VISUAL DEFECTS. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS PERFORMED AT SERVICE AND REPAIR AND THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED HIGH AND IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE COMPLAINT WAS ABLE TO BE REPLICATED, THEREFORE THE COMPLAINT IS CONFIRMED. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED; SOCKET WRENCH VEPTR II. CONCLUSION: 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. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    ADDITIONAL NARRATIVE: (B)(6). 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 (B)(6) 2020, DURING TESTING AT SERVICE AND REPAIR, A SOCKET WRENCH FOR VEPTR NUT FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR SOCKET WRENCH FOR VEPTR NUT THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213548 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.641.004 H130932-12 10705034720128

    Patients

    Seq Age Sex Outcome Treatment
    1