BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 15544457 · Received October 5, 2022

    Report

    Report Number
    8030965-2022-07888
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXC
    UDI-DI
    10705034720128
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. ADDITIONAL NARRATIVE: DATE OF EVENT: ONLY THE EVENT YEAR IS KNOWN. INITIAL REPORTER OCCUPATION: REPORTER IS A J&J EMPLOYEE. PART #: 03.641.004, SYNTHES LOT#: H852117-09, SUPPLIER LOT#: H852117-09, RELEASE TO WAREHOUSE DATE: 23 JAN 2020, SUPPLIER: (B)(4). NO NCR'S GENERATED DURING PRODUCTION. IT WAS REPORTED THAT THE REPAIR TECHNICIANS FOUND THAT THE TORQUE FAILED TEST HIGH FOR THE DEVICE 03.641.004, SOCKET WRENCH FOR VEPTR NUT. THE REPAIR TECHNICIAN REPORTED THAT THE DEVICE FAILED LOW TORQUE DURING EVALUATION. THE CAUSE OF THE ISSUE IS TORQUE TEST FAILED LOW. THE DEVICE MINIMUM PEAK WAS AT 4.851 NM WHICH IS LOWER THAN THE ACCEPTED TORQUE RANGE OF 5 NM-6.4 NM. THE ITEM WILL BE REPAIRED AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND WILL BE RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE 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 THAT ON UNKNOWN DATE, THE REPAIR TECHNICIANS FOUND THAT THE TORQUE FAILED TEST HIGH. NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 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
    2126682 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC SYNTHES GMBH 03.641.004 H852117-09 10705034720128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown