BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE 14.4 VOLT LITHIUM ION BATTERY

    MDR report key: 3200076 · Received July 1, 2013

    Report

    Report Number
    2520274-2013-03962
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    VETERINARY EVENT. FACILITY REPORTS DURING A TENDON REPAIR PROCEDURE ON A CANINE, THE SMALL BATTERY DRIVE WOULD NOT CHARGE. A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, NO DELAY IN PROCEDURE, AND NO HARM TO PATIENT. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297976 SMALL BATTERY DRIVE 14.4 VOLT LITHIUM ION BATTERY HWE SYNTHES USA 120911

    Patients

    Seq Age Sex Outcome Treatment
    1