BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP ENDO-MEDULLARY SYSTEM

    MDR report key: 4456995 · Received December 23, 2014

    Report

    Report Number
    3000327445-2014-00007
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    November 13, 2014
    Report Date
    December 22, 2014
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    HSB
    PMA / PMN Number
    1111232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PTS WITH CONGENITAL TIBIA PSEUDOARTHROSIS (CPT) ARE DIFFICULT TO TREAT. THERE ARE MANY ASPECTS THAT MAY AFFECT SATISFACTORY HEALING OF CPT CASES, SUCH AS THE STABILITY OF THE FIXATION MATERIAL, THE ADEQUATE ALIGNMENT OF THE BONE SEGMENTS, IMMOBILITY AND BONE/ IMPLANT LOAD SHARING AS WELL AS BIOLOGICAL FACTORS. THE INSTABILITY OF THE BONE MAY PRODUCE HIGH STRESSES ON THE IMPLANT UNLESS IMMOBILIZATION (WITH NO WEIGHT BEARING) IS ENSURED UNTIL COMPLETE CONSOLIDATION OF THE FRACTURE. IN THIS CASE, BONE AND IMPLANT FRACTURE OCCURRED BEFORE CONSOLIDATION OF THE BONE. THUS, ALTHOUGH THE PT HAD A LONG LEG CAST AND WAS WHEELCHAIR DRIVEN FOR THE FIRST MONTH, IT SEEMS THAT TOTAL IMMOBILIZATION WAS NOT ACHIEVED. THE GAP IT IS THE SMALLEST LOCKING NAIL IN THE MARKET AND DESIGNED FOR SPECIFIC CONDITIONS WHERE NO OTHER NAIL WOULD FIT AND DEFICIENT BONE QUALITY. DUE TO ITS REDUCED DIAMETER THE GAP IS NOT RECOMMENDED FOR EARLY FULL WEIGHT BEARING. LOAD SHARING AND PROTECTION IS NECESSARY TO ALLOWED PROPER HEALING. LOCKING THE NAIL MAY HAVE PREVENTED THE PSEUDOARTHROSIS FOCUS TO ACHIEVE BONE-TO-BONE CONTACT. LEAVING THE NAIL DISTALLY UNLOCK AND SUPPORTING THE LEG WITH A CAST OR KAFO COULD HAVE BEEN ANOTHER OPTION.

    Description of Event or Problem · 1

    A GAP INTRAMEDULLARY NAIL 4.8 MM DIAMETER IMPLANTED IN A PT SUFFERING FROM SKELETAL DISPLASIA AND CONGENITAL TIBIAL PSEUDOARTHROSIS BROKE IN PT AT THE LEVEL OF THE FIRST DISTAL HOLE. THE INTRAMEDULLARY NAIL WAS IMPLANTED ON (B)(6) 2014 AND REVISED ON (B)(6) 2014. ANALYSIS OF THE X-RAYS OF THE BROKEN NAIL RECEIVED ON (B)(6) 2014 SHOWS THAT ONLY ONE GAP LOCKING SCREW WAS USED DISTALLY AND TWO OTHER SCREWS FROM OTHER SYSTEM WERE USED EXTERNALLY IN A WELL ESTABLISHED SURGICAL TECHNIQUE FREQUENTLY USED BY ORTHOPEDIC SURGEONS. SMALL DIAMETER GAP NAILS REQUIRED A MINIMUM OF 2 DISTAL LOCKING SCREWS DUE TO THE SMALL DIAMETER OF THE SCREWS. THE SURGEON EXPLAINED THAT, AT THE BEGINNING, THE NAIL WAS LOCKED WITH TWO SCREWS. BUT THEN IT SHOWED THAT AN UNACCEPTABLE SPACING OR GAP STILL EXISTED IN BETWEEN THE BONE FRAGMENTS. BECAUSE OF THE THREAD A FURTHER PROXIMAL COMPRESSION WAS NOT POSSIBLE ANYMORE, THEREFORE, THE SCREWS HAD TO BE REMOVED AND THE LAST REMAINING HOLE HAD TO BE USED. A FURTHER LOCKING OF THE HOLES IN THE LATERAL/MEDIAL AREA WAS NOT TECHNICALLY POSSIBLE. THE PUNCTURES IN THE BONES WERE TOO CLOSE TO EACH OTHER AND THIS MAY FURTHER WEAKEN THE BONE. THE TWO EXTERNAL SCREWS WERE USED FOR ADDITIONAL SUPPORT. THESE SCREWS DID NOT GO THROUGH THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847376 GAP ENDO-MEDULLARY SYSTEM GAP NAIL HSB PEGA MEDICAL INC. GAP NAIL, GAP-N48-28 121218-005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention