BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING SCREWDRIVER HANDLE

    MDR report key: 13715196 · Received March 9, 2022

    Report

    Report Number
    2939274-2022-00822
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587035673
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODE: LXH. REPORTER IS A J&J SALES REPRESENTATIVE. A PRODUCT INVESTIGATION WAS CONDUCTED. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT THE 311.023 SWITCH DOES NOT MOVE. THE REPAIR TECHNICIAN REPORTED THE DEVICE PLASTIC HANDLE IS BROKEN. THE THUMB LATCH ALSO FAILED IN FORWARD AND REVERSE. HANDLE CRACKED/BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 311.023. LOT NUMBER: T953195. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 09-DEC-2010 (32 DEVICES), 14-DEC-2010 (43 DEVICES), 22-DEC-2010 (5 DEVICES) A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 AN UNKNOWN DATE, THE RATCHETING SCREWDRIVER HANDLE SWITCH DOES NOT MOVE. THE ISSUE WAS OBSERVED PROACTIVELY PRIOR TO SURGERY IN PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE PLASTIC HANDLE IS BROKEN. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2022. THIS REPORT IS FOR ONE (1) RATCHETING SCREWDRIVER HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270812 RATCHETING SCREWDRIVER HANDLE SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 311.023 T953195 10887587035673

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown