BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCH,BSKT,DCKLING,UPBTR

    MDR report key: 5806951 · Received July 19, 2016

    Report

    Report Number
    1219602-2016-00402
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 22, 2016
    Report Date
    June 22, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION NARRATIVE - ONE DUCKLING UPBITER BASKET PUNCH WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DEVICE CONFIRMED THE REPORTED COMPLAINT OF THE LOWER JAW BREAKING OFF. EXAMINATION OF THE BREAK AREA USING A STEREO MICROSCOPE SHOWED STRIATIONS AT THE REMAINING CUTTING EDGE SURFACE WHICH IS CONSISTENT WITH THE CUTTING EDGE BEING FILED. A CUTTING EDGE IN THIS CONDITION WOULD REQUIRE THE USE OF EXCESSIVE FORCE TO CUT. THIS MANNER OF REPAIR/SHARPENING IS INCONSISTENT WITH CURRENT SMITH+NEPHEW REPAIR PRACTICES. PER THE DEVICES IFU 1060355 REV H UNDER ¿PRECAUTIONS¿ ¿AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE.¿ FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE SCOPE PROCEDURE, A PIECE BROKE OFF OF THE DEVICE AND WAS RETAINED IN THE PATIENT. AN X-RAY WAS PERFORMED TO ATTEMPT TO REMOVE THE BROKEN PIECE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459552 PCH,BSKT,DCKLING,UPBTR ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 50396320

    Patients

    Seq Age Sex Outcome Treatment
    1