BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 14654500 · Received June 10, 2022

    Report

    Report Number
    2939274-2022-02211
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWE
    UDI-DI
    10887587024585
    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. INITIAL REPORTER OCCUPATION: REPORTER IS A J&J EMPLOYEE. PART #: 05.000.008, SYNTHES LOT #: 003664, SUPPLIER LOT #: 003664, RELEASE TO WAREHOUSE DATE: AUGUST 24, 2010, SUPPLIERS: TRIANGLE MANUFACTURING. 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. THE REPAIR TECHNICIAN REPORTED THE DEVICE HAD DIRTY MEMBRANE VENT. THE DEVICE DID NOT RUN IN FAST FORWARD, FORWARD AND REVERSE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE REPAIRED PER THE INSPECTION SHEET, AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 10. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN TUNGSTEN DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS CONFIRMED. 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 AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION IT WAS OBSERVED THAT HAND PIECE FOR BATTERY POWERED DRIVER TURNS ON AUTOMATICALLY. THE ISSUE WAS OBSERVED DURING PREVENTIVE MAINTENANCE PRIOR TO SURGERY. THERE WAS NO PATIENT AND HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 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
    726274 HAND PIECE FOR BATTERY POWERED DRIVER INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE WRIGHTS LANE SYNTHES USA PRODUCTS LLC 05.000.008 003664 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown