BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROACH HANDLE

    MDR report key: 2211056 · Received August 5, 2011

    Report

    Report Number
    3004608878-2011-00110
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 5, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE RPTR STATED THAT DURING A SURGICAL PROCEDURE USING THE UNI2 TOTAL WRIST IMPLANT SYSTEM, THE BROACH HANDLE PIN THAT HOLDS THE BROACH ON ITS HANDLE AND ADJUSTS BETWEEN THE MINIMAL AND STANDARD SETTINGS BROKE AFTER BEING HIT WITH THE MALLET (AS DESCRIBED IN THE SURGICAL TECHNIQUE). THE PIN BROKE INTO TWO PIECES. THE BROKEN PARTS FELL ONTO THE SCRUB TABLE. NO CLINICAL INTERVENTION WAS REQUIRED. THERE WAS NO ADVERSE OUTCOME FOR THE PT. SURGERY TIME WAS NOT INCREASED SIGNIFICANTLY. INTEGRA HAS REQUESTED THE RETURN OF THE INSTRUMENT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROACH HANDLE UNI2 TOTAL WRIST IMPLANT SYSTEM HRS INTEGRA, CINCINNATI

    Patients

    Seq Age Sex Outcome Treatment
    1