BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW ATTCHMT/LARGE W/KEY FOR SMALL BATTERY DRIVE

    MDR report key: 3132420 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02358
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 REPORTERS COMPLAINT OF INTERMITTENT OPERATION WAS CONFIRMED. THE OSCILLATING SAW ATTACHMENT WAS TESTED AND THE COMPLAINT WAS DUPLICATED. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME. PLACEHOLDER.

    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 SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A VETERINARY FACILITY, DURING A TIBIAL PLATEAU LEVELING OSTEOTOMY (TPLO) ON (B)(6) 2013, THE OSCILLATING SAW ATTACHMENT WAS RUNNING INTERMITTENTLY AND LEAKING A BROWNISH FLUID. THE SURGEON WAS ABLE TO USE ANOTHER SAW ATTACHMENT TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THERE WAS NO ADVERSE EVENT TO ANIMAL. THIS REPORT IS FOR A OSCILLATING SAW ATTCHMT/LARGE W/KEY FOR SMALL BATTERY DRIVE. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235054 OSCILLATING SAW ATTCHMT/LARGE W/KEY FOR SMALL BATTERY DRIVE HWE SYNTHES GMBH 1222-R

    Patients

    Seq Age Sex Outcome Treatment
    1