BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 19751369 · Received July 16, 2024

    Report

    Report Number
    8030965-2024-08776
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    April 29, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    7611819890084
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D2B: ADDITIONAL DEVICE PRODUCT CODES: GXL, HXX E3: REPORTER IS A J&J EMPLOYEE. H3, H4, H6: THE CUSTOMER REPORTED THAT THE ITEM HAND PIECE FOR BATTERY POWERED DRIVER NONE OF THE BUTTONS ARE RESPONDING. THE REPAIR TECHNICIAN REPORTED THAT THE DEVICE DOSE NOT RUN IN FAST FORWARD, FORWARD AND REVERSE. RUST WAS PRESENT ON MOTOR, WIRES WERE DISCOLORED, AND DEBRIS WAS PRESENT ON INTERNAL COMPONENT. THE CAUSE OF THE ISSUE IS IMPROPER MAINTENANCE. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 8-JULY-2024 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. FINALIZED SERVICE RECORD WILL BE ARCHIVED. 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. DEVICE HISTORY REVIEW (DHR): PART# 05.000.008, SYNTHES LOT # 5744464, SUPPLIER LOT# 001932, RELEASE TO WAREHOUSE DATE: MAR-19-2008, SUPPLIER: (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. 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 ON APRIL 29, 2024, NONE OF THE BUTTONS WERE RESPONDING ON THE HAND PIECE FOR BATTERY POWERED DRIVER. THIS WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER EVALUATION OF THE RETURNED PRODUCT, IT WAS NOTED THAT THE ITEM HAD FOREIGN MATERIAL PRESENT ON IT. THIS REPORT INVOLVES ONE 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
    722101 HAND PIECE FOR BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 7611819890084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown