BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 10133310 · Received June 9, 2020

    Report

    Report Number
    2939274-2020-02718
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    January 1, 2020
    Report Date
    May 28, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: CORRECTION: B5. H6: PATIENT CODES. ADDITIONAL INFORMATION: D4: LOT. H3, H6: PART NUMBER:03.641.004, SYNTHES LOT NUMBER: H130932-23, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: OCTOBER 19, 2016, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE SOCKET WRENCH FOR VEPTR NUT (PART # 03.641.004 / LOT # H130932-23) WAS RECEIVED AT US CUSTOMER (CQ). BESIDES NORMAL SURFACE WEAR, NO VISUAL DEFECTS WERE IDENTIFIED WITH THE RETURNED DEVICE. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE DEVICE FAILED CALIBRATION. THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED THE TORQUE TEST. TORQUE TEST HIGH IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS FAILED HIGH. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. FUNCTIONAL TEST: FUNCTIONAL TESTING WAS PERFORMED BY SERVICE AND REPAIR. WHILE BEING FUNCTIONALLY TESTED, THE SOCKET WRENCH TESTED HIGH AT 7.88NM WHICH WAS NOT WITHIN THE SPECIFIED TORQUE RANGE OF THE DEVICE OF 5.0 NM - 6.4 NM. THE OVERALL COMPLAINT WAS CONFIRMED AS THE WRENCH WAS OUT OF CALIBRATION AND TESTED HIGH. IT WAS ALSO IDENTIFIED AT SERVICE AND REPAIR THAT THE DEVICE WAS OVER 3 YEARS OLD THUS NOT REPAIRABLE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED AS INTERNAL COMPONENTS WERE NOT ACCESSIBLE WITHOUT DEVICE DESTRUCTION. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: CURRENT & MANUFACTURED SOCKET WRENCH. DEPUY/SYNTHES TORQUE HANDLE TESTING CALIBRATION VERIFICATION. IT WAS IDENTIFIED THAT THE RETURNED INSTRUMENT HAS EXCEEDED THE EXPECTED INSTRUMENT LIFE (THREE YEARS) ESTABLISHED BY BRADSHAW, THEREFORE ANY RECALIBRATION COULD NOT BE ASSURED. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE SOCKET WRENCH FOR VEPTR NUT FAILED CALIBRATION. THE RETURNED INSTRUMENT HAS EXCEEDED THE EXPECTED INSTRUMENT LIFE (THREE YEARS) ESTABLISHED BY BRADSHAW, THEREFORE ANY RECALIBRATION COULD NOT BE ASSURED. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED ON MAY 28, 2020, DURING TESTING AT SERVICE AND REPAIR, THE TECHNICIAN FOUND THAT THE SOCKET WRENCH FOR VEPTR NUT FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(6). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. 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 ON AN UNKNOWN DATE THAT THE SOCKET RENCH WAS FAILED CALIBRATION. THERE WAS NO SURGERY OR PATIENT INVOLVED. THIS REPORT IS FOR ONE (1) SOCKET RENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597524 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.641.004 H130932-23 10705034720128

    Patients

    Seq Age Sex Outcome Treatment
    1