BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS BAR BENDER

    MDR report key: 5017696 · Received August 20, 2015

    Report

    Report Number
    0001032347-2015-00358
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 23, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALS MINIMAL WEAR AND CONFIRMS THE BROKEN/MISSING COMPONENT (ROLLER PIN ASSEMBLY). FUNCTIONAL TESTS COULD NOT BE PERFORMED AS A RESULT OF THE MISSING/BROKEN COMPONENT. THE DEVICE HISTORY WAS REVIEWED AND NO NON-CONFORMANCE WAS FOUND FOR THIS LOT. THERE ARE NO INDICATION OF MANUFACTURING DEFECTS. BASED ON THE PRODUCTS HISTORY, THE MOST PROBABLE ROOT CAUSE IS THAT THE INSTRUMENT'S RETAINING RING FELL OUT OF THE ROLLER PIN ASSEMBLY WHICH CAUSED THE ROLLER PIN ASSEMBLY TO FALL OUT. INVESTIGATIONS PERFORMED CONCLUDED THAT THE ONLY WAY THESE RINGS CAN LOOSE THEIR ORIGINAL SHAPE IS BY INCORRECTLY USING THE INSTRUMENT LEAVING A SIGNIFICANT GAP BETWEEN THE PECTUS BAR AND THE BENDER.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED A BENDER BROKE DURING SURGERY. NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552707 PECTUS BAR BENDER BENDER HXW BIOMET MICROFIXATION N/A MS0008

    Patients

    Seq Age Sex Outcome Treatment
    1