BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 20482966 · Received October 18, 2024

    Report

    Report Number
    8030965-2024-12967
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 9, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    10887587024585
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: H3, H6: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT ON AN UNKNOWN DATE, BPD'S DISCOVERED NOT WORKING IN STERILE PROCESSING. THE REPAIR TECHNICIAN REPORTED FORWARD AND REVERSE WAS INTERMITTENT, GRINDING SOUND WHEN RUNNING THE MOTOR, DISCOLORED VENT AND WIRE, COSMETIC TEST FAILED, RUST ON MOTOR, DEBRIS ON BARRIER, CONTACT PLATE BROKE UPON REASSEMBLY. THE CAUSE OF THE ISSUE IS IMPROPER MAINTENANCE. THE FOLLOWING PARTS WERE REPLACED: ISO SCREWS. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED MEDTECH ORTHOPEDICS 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. H3, H4, H6: DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED: PART: 05.000.008. SYNTHES LOT: 003532. SUPPLIER LOT: 003532. RELEASE TO WAREHOUSE DATE: DEC 03, 2018SUPPLIER: (B)(4). NO NCRS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, HAND PIECE FOR BATTERY POWERED DRIVERS DISCOVERED NOT WORKING IN STERILE PROCESSING. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011077 HAND PIECE FOR BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown