BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 10489636 · Received September 3, 2020

    Report

    Report Number
    2939274-2020-03972
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Report Date
    August 10, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXC
    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 · 1

    INVESTIGATION SUMMARY: INVESTIGATION FLOW: FUNCTIONAL/DEVICE INTERACTION. VISUAL INSPECTION: THE SOCKET WRENCH FOR VEPTR NUT (P/N: 03.641.004, LOT NUMBER: H130932-11) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED NO EXTERNAL DAMAGE. SERVICE AND REPAIR EVALUATION: UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2020, DURING TESTING AT SERVICE & REPAIR IT WAS FOUND OUT THAT THE SOCKET WRENCH FAILED IN 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. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE COMPLAINT DEVICE AT SERVICE AND REPAIR. THE DEVICE TORQUE TESTED HIGH. THE COMPLAINT WAS ABLE TO BE REPLICATED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DEVICE IS OUT OF CALIBRATION. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 LOT. SERVICE AND REPAIR HISTORY: THE PREVIOUS SERVICE EVENT FOR PART NUMBER 03.641.004 WITH LOT NUMBER(S) H130932-11 HAS BEEN REVIEWED. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(6) 2020 FOR OUT OF CALIBRATION . THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON (B)(6) 2018 DUE TO OUT OF CALIBRATION. THE PREVIOUS SERVICE CONDITION OF OUT OF CALIBRATION IS RELEVANT TO THE CURRENT COMPLAINED ISSUE OF OUT OF CALIBRATION. THE MANUFACTURE DATE OF THIS ITEM IS (B)(6) 2016. THE SERVICE HISTORY REVIEW IS CONFIRMED. 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, DURING TESTING AT SERVICE & REPAIR IT WAS FOUND OUT THAT THE SOCKET WRENCH FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952788 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC H130932-11

    Patients

    Seq Age Sex Outcome Treatment
    1