BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 11855673 · Received May 20, 2021

    Report

    Report Number
    2939274-2021-02460
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Report Date
    April 23, 2021
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. PART NUMBER:05.000.008. SYNTHES LOT NUMBER: 003797. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: 14OCT2010. EXPIRATION DATE: N/A. SUPPLIER: TRIANGLE MANUFACTURING. NO 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. SERVICE AND REPAIR HISTORY: THE PREVIOUS SERVICE EVENT FOR PART NUMBER 05.000.008 WITH LOT NUMBER(S) 003797 HAS BEEN REVIEWED. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(6) 2021 FOR UNKNOWN MALFUNCTION. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON (B)(6) 2015 DUE TO MOTOR FAILURE. THE PREVIOUS SERVICE CONDITION OF MOTOR FAILURE IS NOT RELEVANT TO THE CURRENT COMPLAINED ISSUE OF UNKNOWN MALFUNCTION. THE MANUFACTURE DATE OF THIS ITEM IS 14-OCT-2010. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. SERVICE AND REPAIR EVALUATION: DURING EQUIPMENT CHECK POST WASH THE HAND PIECE FOR BATTERY POWERED DRIVER NEEDS REPAIR FOR UNKNOWN MALFUNCTION. THE REPAIR TECHNICIAN REPORTED THAT THERE IS DEBRIS IN THE HOUSING AND BEARINGS ARE GRINDING. 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 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 UNKNOWN DATE, DURING AN EQUIPMENT CHECK POST WASH, THE HAND PIECE FOR BATTERY POWERED DRIVER NEEDS TO BE REPAIRED FOR AN UNKNOWN MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 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
    756348 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 05.000.008 003797 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1