BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 11879199 · Received May 25, 2021

    Report

    Report Number
    2939274-2021-02559
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Report Date
    April 2, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWE
    UDI-DI
    10887587024585
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: GXL, HXX. REPORTER IS A J&J SALES REPRESENTATIVE. A PRODUCT INVESTIGATION WAS CONDUCTED. SERVICE AND REPAIR EVALUATION: THE REPAIR TECHNICIAN REPORTED THE BEARINGS WERE GRINDING, THERE WAS DEBRIS IN THE HOUSING, WIRES BURNT. THE DEVICE DID NOT RUN IN FAST FORWARD, FORWARD, OR REVERSE. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS DAMAGED COMPONENT. THE FOLLOWING PARTS WERE REPLACED: CIRCUIT BOARD, MOTOR, MEMBRANE SWITCH/FLEX CIRCUIT, AND ALL APPLICABLE COMPONENTS. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 12-APR-2021 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 05.000.008. SYNTHES LOT # 003315. SUPPLIER LOT # 003315. RELEASE TO WAREHOUSE DATE: 02 APR 2010. SUPPLIER: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION IT WAS DISCOVERED THAT THE HAND PIECE FOR BATTERY POWERED DRIVER DOES NOT WORK CONSISTENTLY. DIFFERENT BATTERIES TRIED TO CONFIRM, BUT IT STOPS WHILE BUTTON PUSHED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE BEARINGS WERE GRINDING AND THERE WAS DEBRIS IN THE HOUSING, WIRES BURNT. THE DEVICE DID NOT RUN IN FAST FORWARD, FORWARD, OR REVERSE. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) HAND PIECE FOR BATTERY POWERED DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777022 HAND PIECE FOR BATTERY POWERED DRIVER INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE WRIGHTS LANE SYNTHES USA PRODUCTS LLC 05.000.008 003315 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1