BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 14463776 · Received May 20, 2022

    Report

    Report Number
    2939274-2022-01829
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    December 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
    MA, US
    Reporter Occupation
    OTHER

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PRODUCT COMPLAINT # (B)(4). REPORTER IS A J&J EMPLOYEE. INVESTIGATION SUMMARY SERVICE AND REPAIR HISTORY. THE PREVIOUS SERVICE EVENT FOR PART NUMBER 05.000.008 WITH LOT NUMBER(S) 003429 HAS BEEN REVIEWED. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON 2-DEC-2021 FOR DOES NOT WORK. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 27-JUL-2017 DUE TO ELECTRONIC CONTROL DAMAGED. THE PREVIOUS SERVICE CONDITION OF ELECTRONIC CONTROL DAMAGED IS RELEVANT TO THE CURRENT COMPLAINED ISSUE OF DOES NOT WORK. THE MANUFACTURE DATE OF THIS ITEM IS 13-MAY-2010. THE SERVICE HISTORY REVIEW IS CONFIRMED. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT THE HAND PIECE FOR BATTERY POWERED DRIVER REVERSE DOES NOT WORK. THE REPAIR TECHNICIAN REPORTED THE DEVICE RAN LOW IN FAST FORWARD AND FORWARD AND DID NOT RUN IN REVERSE. THE CAUSE OF THE ISSUE IS DAMAGED COMPONENT. THE ITEM WILL BE REPAIRED PER THE INSPECTION SHEET, AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 10. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN TUNGSTEN DOCUMENT MANAGEMENT SYSTEM. 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. UPDATE (B)(6)2022. SERVICE AND REPAIR EVALUATION. THE CUSTOMER REPORTED HAND PIECE FOR BATTERY POWERED DRIVER REVERSE DOES NOT WORK. THE REPAIR TECHNICIAN REPORTED THE DEVICE RAN LOW IN FAST FORWARD AND FORWARD AND DID NOT RUN IN REVERSE, MEMBRANE VENT WAS DIRTY. WARRANTY REPLACED IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS DAMAGED COMPONENT. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. DEVICE HISTORY LOT A SHR WAS PERFORMED ON THE SERVICEABLE DEVICE AND IT WAS FOUND THAT THE DEVICE WAS MANUFACTURED ON 13-MAY-2010. A MANUFACTURING RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE 100673626 NO MANUFACTURING RECORD EVALUATION IS REQUIRED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS. IT WAS REPORTED THAT ON (B)(6), 2021, THE HAND PIECE FOR BATTERY POWERED DRIVER REVERSE DOES NOT WORK. THE ISSUE WAS OBSERVED DURING WEEKLY AUDIT OF EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE 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
    526502 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 003429 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown