BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3192606 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04116
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS 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

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN EVALUATION WAS CONDUCTED. THE CUSTOMER'S COMPLAINT THAT THIS DEVICE FELL APART WAS CONFIRMED. A VISUAL INSPECTION WAS CONDUCTED WHICH CONFIRMED THAT THE SELECTOR SWITCH BECAME DETACHED. THIS IS DUE TO THE DEVICE BEING DROPPED.

    Description of Event or Problem · 1

    THIS IS A VETERINARY EVENT. DURING A TIBIAL PLATEAU LEVELING OSTEOMY (TPLO) ON A CANINE, THE SMALL BATTERY DRIVE FELL APART. THE CIRCULAR BAND AROUND THE DRILL AT THE LOCKING INSERTION POINT FELL OFF OF THE DRILL. THE PROCEDURE WAS DELAYED APPROXIMATELY 5 MINUTES WHILE A SPARE BATTERY DRIVE WAS RETRIEVED. THE SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM AND NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292471 SMALL BATTERY DRIVE HWE SYNTHES GMBH 004197

    Patients

    Seq Age Sex Outcome Treatment
    1