BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE 14.4V BATTERY

    MDR report key: 2983229 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-00680
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED OR DUPLICATED; THE UNIT WAS TESTED AND PASSED ALL OPERATIONAL SPECIFICATIONS, AND NO PROBLEMS WERE NOTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PATIENT IS A CANINE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    A SMALL BATTERY DRIVE 14.4V BATTERY, IN A TIBIAL PLATEAU LEVELING OSTEOTOMY, TPLO, SURGERY HAD LOW POWER. THEY TRIED THE BATTERY WITH 2 DIFFERENT CASINGS, BUT IT STILL HAD LOW POWER. NO INJURIES OR MEDICAL INTERVENTION WAS REPORTED. NO DELAY IN SURGERY AS THEY SWAPPED IT OUT FOR ANOTHER BATTERY. THE PATIENT WAS A CANINE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88657 SMALL BATTERY DRIVE 14.4V BATTERY SMALL BATTERY DRIVE MOQ SYNTHES GMBH D100826

    Patients

    Seq Age Sex Outcome Treatment
    1