BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3113011 · Received May 15, 2013

    Report

    Report Number
    8030965-2013-02195
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS USED AS A VETERINARY PRODUCT IN A VETERINARY PROCEDURE. DEVICE IS MARKETED FOR HUMAN USE. THE HEALTH PROFESSIONAL REFERS TO THE VETERINARIAN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    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 DOES NOT WORK AT ALL WAS CONFIRMED. THE DEVICE WAS TESTED AND THE COMPLAINT WAS DUPLICATED. THIS IS DUE TO USAGE AND WEAR OVER TIME. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS DURING A TPLO PROCEDURE ON A CANINE ON (B)(6) 2013, THE SMALL BATTERY DRIVE STOPPED WORKING. IT IS REPORTED THE PROCEDURE WAS DELAYED APPROXIMATELY 45 MINUTES WHILE A SPARE DEVICE WAS RETRIEVED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214065 SMALL BATTERY DRIVE HWE SYNTHES GMBH 004201

    Patients

    Seq Age Sex Outcome Treatment
    1