BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 10373601 · Received August 6, 2020

    Report

    Report Number
    2939274-2020-03414
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Report Date
    July 16, 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. VISUAL INSPECTION: THE SOCKET WRENCH FOR VEPTR NUT (P/N: 03.641.004, LOT #: H130932-17) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, SLIGHT DISCOLORATION WAS OBSERVED AND THE ETCH ON THE DEVICE STARTED TO FADE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS PERFORMED ON THE RETURNED DEVICE AT SERVICE AND REPAIR. THE HIGHEST TORQUE OF THE DEVICE MEASURED DURING CALIBRATION TESTING WAS 7.773 NM WHICH WAS NOT WITHIN THE SPECIFIED TORQUE RANGE OF THE DEVICE OF 5.32 NM - 6.08 NM. HENCE, THE TORQUE TEST FAILED HIGH. SERVICE AND REPAIR HISTORY: THE PREVIOUS SERVICE EVENT FOR PART NUMBER 03.641.004 WITH LOT NUMBER(S) H130932-17 HAS BEEN REVIEWED. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON 16-JUL-2020 FOR OUT OF SPECIFIED CALIBRATION. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 15-FEB-2018 DUE TO TESTED OK. THE PREVIOUS SERVICE CONDITION OF TESTED OK IS NOT RELEVANT TO THE CURRENT COMPLAINED ISSUE OF OUT OF SPECIFIED CALIBRATION. THE MANUFACTURE DATE OF THIS ITEM IS 19-OCT-2016. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. SERVICE AND REPAIR EVALUATION: IT WAS REPORTED ON (B)(6) 2020, DURING EVALUATION AT SERVICE AND REPAIR, THE SOCKET WRENCH FOR VEPTR NUT WAS FOUND TO HAVE FAILED CALIBRATION. THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED CALIBRATION. 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. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED -LOANER SET SPECS- CALIBRATION SPECIFICATIONS -SOCKET WRENCH. COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED FAILED HIGH IN CALIBRATION TESTING. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS CONFIRMED FOR THE SOCKET WRENCH FOR VEPTR NUT (P/N: 03.641.004, LOT #: H130932-17). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO DEVICE MAINTENANCE. 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 HISTORY PART #: 03.641.004, SYNTHES LOT NUMBER: H130932-17, SUPPLIER LOT #: H130932-17, RELEASE TO WAREHOUSE DATE: 19-OCT-2016, SUPPLIER: (B)(4). 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. 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

    REPORTER IS JNJ REPRESENTATIVE. 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 (B)(6) 2020 THAT CALIBRATION FAILED ISSUE FOUND DURING SYNTHES INTERNAL INSPECTION TESTING AT SERVICE & REPAIR. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) 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
    839648 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.641.004 H130932-17 10705034720128

    Patients

    Seq Age Sex Outcome Treatment
    1