BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 11194949 · Received January 19, 2021

    Report

    Report Number
    2939274-2021-00364
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Report Date
    November 30, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587024585
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: GXL AND HWE. PART 05.000.008, LOT 006336 (PREVIOUS LOT 003463): RELEASE TO WAREHOUSE DATE: APRIL 20, 2016. MANUFACTURED BY SYNTHES (B)(4). NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE FAST FORWARD AND REVERSE DOES NOT WORK. THE REPAIR TECHNICIAN REPORTED THE DEVICE DOES NOT RUN IN FORWARD, FAST FORWARD, OR REVERSE AND THE BEARINGS AND COLUMN WERE COVERED IN DEBRIS. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS DAMAGED COMPONENT. THE FOLLOWING PARTS WERE REPLACED: MOTOR, CIRCUIT BOARD, MEMBRANE SWITCH & FLEX CIRCUIT, AND ALL APPLICABLE COMPONENTS. THE ITEM WILL BE REPAIRED PER THE INSPECTION SHEET 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 · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE HANDPIECE FOR BATTERY POWERED DRIVER FAST FORWARD AND REVERSE DOES NOT WORK. THE ISSUE WAS OBSERVED DURING WEEKLY AUDIT. THERE WAS NO PATIENT INVOLVEMENT. DURING THE MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS NOTED, THE DEVICE DOES NOT RUN IN FORWARD, FAST FORWARD, OR REVERSE AND THE BEARINGS AND COLUMN WERE COVERED IN DEBRIS. THIS REPORT IS FOR A HAND PIECE FOR BATTERY POWERED DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90270 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 05.000.008 006336 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1