BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM/2.7MM T-PLATE

    MDR report key: 2982409 · Received February 26, 2013

    Report

    Report Number
    3003506883-2013-10023
    Event Type
    Injury
    Date Received
    February 26, 2013
    Report Date
    February 8, 2011
    Manufacturer
    SYNTHES (USA) ELMIRA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND IT WAS NOTED THAT THE PLATE WAS IN TWO PIECES RESULTING FROM FRACTURES LOCATED AT THE SECOND SHAFT HOLE. THE FRACTURES WERE IN LINE WITH THE CENTER OF THE HOLE, AND WERE CLEAN BRAKES WITH NO INDICATION OF TEARING. FURTHER VISUAL EXAMINATION OF THE HEAD PIECE DEMONSTRATED AN UPWARD BEND ORIGINATING NEAR THE FIRST SHAFT HOLE AND ENDING AT THE BREAKAGE AREA. THE UNDERSIDE OF THE HEAD PIECE HAD THREE SMALL GOUGES WHICH APPEARED TO BE HAND TOOL MARKS. THE OTHER HALF OF THE BROKEN PLATE SHOWED A WEAR MARK LOCATED ON THE FIFTH SHAFT HOLE, WITH SIMILAR MARKS ON THE FIRST HOLE. THE PARTS RETURNED MET ALL DIMENSIONAL REQUIREMENTS, AND THE CONDITIONS NOTED DURING VISUAL EXAMINATION WERE CONSIDERED THE RESULT OF FIELD USAGE. THE ROOT CAUSE WAS INDETERMINATE. SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATE BROKE AT THE SECOND HOLE ON TOP OF THE SHAFT AFTER BEING IN THE DOG'S RIGHT LEG. THE PATIENT IS A (B)(6) LABRADOR RETRIEVER. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81095 3.5MM/2.7MM T-PLATE HRS SYNTHES (USA) ELMIRA 6511614

    Patients

    Seq Age Sex Outcome Treatment
    1