BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3140679 · Received May 31, 2013

    Report

    Report Number
    8030965-2013-02600
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RECEIVED FOR EVALUATION. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE CUSTOMERS COMPLAINT THAT THIS DEVICE WILL NOT SECURE AN ATTACHMENT WAS CONFIRMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED WHICH CONFIRMED THAT THE COUPLER IS DAMAGED. THIS IS DUE TO NORMAL WEAR OVER TIME. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4).

    Description of Event or Problem · 1

    THIS IS A VETERINARY EVENT. THE FACILITY REPORTS, DURING A TIBIAL PLATEAU LEVELING OSTEOTOMY (TPLO) PROCEDURE, THE SMALL BATTERY DRIVE ATTACHMENT WOULD NOT SECURE. THE PROCEDURE WAS DELAYED APPROXIMATELY 30 MINUTES WHILE ANOTHER SMALL BATTERY DRIVE WAS RETRIEVED. THE SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THERE WAS NO HARM TO PATIENT NOTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241772 SMALL BATTERY DRIVE HWE SYNTHES GMBH 4159

    Patients

    Seq Age Sex Outcome Treatment
    1