BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE BATTERY POWERED DRIVER

    MDR report key: 19481286 · Received June 6, 2024

    Report

    Report Number
    8030965-2024-07102
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    07611819890084
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. THE CUSTOMER REPORTED 05.000.008, HAND PIECE FOR BATTERY POWERED DRIVER HAS AN UNKNOWN ALLEGATION. THE REPAIR TECHNICIAN REPORTED THAT DEVICE RUN INTERMITTENT IN FAST FORWARD, FORWARD AND REVERSE MODE, DAMAGED WIRES, RUST ON MOTOR, BLACK DEBRIS ON INTERNAL COMPONENTS. THE CAUSE OF THE ISSUE IS USER ERROR. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON (B)(6) 2024 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN MDS&R. 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 HISTORY PART NUMBER: 05.000.008, SYNTHES LOT NUMBER: 005208 WAS 5467409, SUPPLIER LOT NUMBER: 001320, RELEASE TO WAREHOUSE DATE: 11 MAR 2007, SUPPLIER: (B)(4). MRR # 121572 WAS ISSUED DURING MANUFACTURING, 53 PIECES WERE REWORKED USING NORMAL MANUFACTURING PROCESSES. ALL CONTACT PLATES WERE REPLACED USING NYTEMP SCREWS. UNITS WERE REPORTED TO CONFORM TO DCO # 10004702. ALL UNITS WERE INSPECTED. RELEVANCE TO COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. 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 THE ITEM HAND PIECE FOR BATTERY POWERED DRIVER HAS AN UNKNOWN ALLEGATION. IT IS UNKNOWN WHEN THE INCIDENT WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT OR REPORTS OF IMPACT TO SURGERY. THIS REPORT IS FOR HANDLE BATTERY POWERED DRIVER THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423639 HANDLE BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 07611819890084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown