BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 19750501 · Received July 16, 2024

    Report

    Report Number
    8030965-2024-08765
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    April 24, 2024
    Report Date
    July 16, 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. D2B: ADDITIONAL DEVICE PRODUCT CODES: GXL, HXX. E3: REPORTER IS A J&J EMPLOYEE. H3, H4, H6: THE CUSTOMER REPORTED THAT HE BATTERY POWERED DRIVER WAS NOT WORKING PROPERLY. RATCHETING SCREWDRIVERS WERE NOT FUNCTIONING PROPERLY. THE REPAIR TECHNICIAN REPORTED THAT DISCOLOR MEMBRANE VENT, CONTACT PLATE WAS CRACKED, DEVICE RAN INTERMITTENT IN REVERSE MODE, DISCOLORED WIRE, RUST ON MOTOR, DEBRIS ON INTERNAL COMPONENTS, DAMAGED SWITCH PLATE, SCRAPPING HOUSING DUE TO PATINA DAMAGE . THE CAUSE OF THE ISSUE IS IMPROPER MAINTENANCE. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 8-JUL-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 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:6217446 SUPPLIER LOT:003122 RELEASE TO WAREHOUSE DATE: SEP 02, 2009 MANUFACTURED BY: TRIANGLE MANUFACTURING 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 24, 2024, THE BATTERY POWERED DRIVER WAS NOT WORKING PROPERLY. RATCHETING SCREWDRIVERS WERE NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER INVESTIGATION OF THE RETURNED DEVICES, DAMAGE TO THE ITEM WAS IDENTIFIED. THIS REPORT INVOLVES ONE HAND PIECE FOR BATTERY POWERED DRIVER. THIS IS REPORT 8 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694247 HAND PIECE FOR BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 003122 7611819890084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown