BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 3829628 · Received April 17, 2014

    Report

    Report Number
    3000327445-2014-00001
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 11, 2014
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    HSB
    PMA / PMN Number
    111232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONSIDERING THAT THERE WAS NO ASSOCIATED TRAUMA TO THE PT AND NO APPARENT FRACTURE ON THE BONE, THE MOST LIKELY FAILURE MODE WOULD BE THE BREAKAGE UNDER CYCLIC LOADING. THEREFORE, IT APPEARS TO BE A FATIGUE FAILURE OF THE IMPLANT. NEVERTHELESS, THE CAUSES OF THE FATIGUE FAILURE ARE STILL UNCLEAR. A COMBINATION OF FACTORS SUCH AS, THE POSITIONING OF THE IMPLANT AND THE ABSENCE OF DISTAL FIXATION LEADING TO SPECIFIC LOADING CONDITIONS, THE PARTICULAR BONE CONDITION OF THE PT AND THE SIZE (LENGTH AND DIAMETER) OF THE IMPLANT MAY HAVE CONTRIBUTED TO THE FAILURE. THEREFORE, FURTHER EVAL WILL BE NECESSARY. FATIGUE TESTING TO SIMULATE IN-VIVO FAILURE MODE IS CURRENTLY ON-GOING. ADDITIONALLY, FOLLOW UP OF OTHER PTS WITH THE SAME IMPLANT SIZES WILL BE DONE TO MONITOR ANY POSSIBLE RE-OCCURRENCE. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVAL WILL BE COMPLETED. MOREOVER, THE MFG AND INSPECTION PROCESS WERE REVIEWED. NO SPECIFIC PROBLEM WAS DETECTED THAT COULD EXPLAIN THE FAILURE. MATERIAL, PROCESS AND DIMENSIONAL SPECIFICATIONS WERE MET FOR THIS BATCH.

    Description of Event or Problem · 1

    THE PT SUFFERING FROM FIBROUS DYSPLASIA (MCCUNE-ALBRIGHT SYNDROME) WAS TREATED ON (B)(6) 2012. EXISTING HARDWARE (FLEXIBLE NAIL) WAS REMOVED. AN INTERTROCHANTERIC OSTEOTOMY WAS PERFORMED TO CORRECT THE PROXIMAL FEMORAL DEFORMITY THE BONE WAS FIX USING A GAP NAIL (DIA 4.8, L=160MM) CONSTRUCT WITH LAGS SCREWS (2X50MM) AND SHORT PLATE. DISTALLY, THE NAIL WAS NOT LOCKED. APPROXIMATELY 15 MONTHS LATER, FOLLOWING A ROUTINE X-RAY, A DISTAL FRACTURE OF IMPLANT WAS OBSERVED. THERE WAS NO ASSOCIATED TRAUMA TO THE PT (E.G. FALL, ACCIDENT). FROM THE X-RAY, THERE APPEARS TO BE ON TRAUMA OR DAMAGE TO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234981 GAP ENDO-EXO MEDULLARY SYSTEM GAP NAIL HSB PEGA MEDICAL INC. GAP NAIL, N48-16 110913-001

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other