BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 20953153 · Received December 17, 2024

    Report

    Report Number
    8030965-2024-15138
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 4, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    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

    PRODUCT COMPLAINT (B)(4). 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. ADDITIONAL NARRATIVE: H3, H6: PRODUCT INVESTIGATION: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT IT WAS REPORTED BUTTONS WERE NOT WORKING. THE REPAIR TECHNICIAN REPORTED THAT DISCOLORED, DAMAGED VENT, CRACKED CONTACT PLATE, DISCOLORED BUTTON, COSMETICS TEST FAILED, DEVICE DOES NOT RUN IN FAST FORWARD, FORWARD AND REVERSE CONDITION AND ALSO DISCOLORED WIRES, DEBRIS ON INTERNAL COMPONENT, RUST ON MOTOR, RUST ON BEARING SPACES, DAMAGED DRIVE COLUMN. THE CAUSE OF THE ISSUE IS IMPROPER MAINTENANCE. 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 NOT 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 # 003371. SUPPLIER LOT # 003371. RELEASE TO WAREHOUSE DATE: 28 APR 2010. SUPPLIER: (B)(4). NO NCR'S 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. 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 BUTTONS OF HAND PIECE FOR BATTERY POWERED DRIVER WERE NOT WORKING. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438286 HAND PIECE FOR BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown