BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 7024387 · Received November 13, 2017

    Report

    Report Number
    3000327445-2017-00005
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    October 14, 2017
    Report Date
    November 10, 2017
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    HSB
    PMA / PMN Number
    K160545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS GAP-N56-28 NAIL WAS INSERTED INTO A (B)(6) YEAR-OLD OVERWEIGHT FEMALE PATIENT WITH OSTEOPOROTIC BONE (WEAK BONE). THE FEMUR PRESENTED WITH A NARROW SHAFT AND A VALGUS DEFORMATION. THE FAILURE OCCURRED APPROXIMATELY THREE WEEKS POST-SURGERY WHILE THE PATIENT WAS SITTING TO PUT HER SHOE ON. THE WEIGHT OF THE PATIENT (AROUND 60 KG) WAS WELL ABOVE THE WEIGHT LIMIT OF THE NAIL, WHICH IS AROUND 40 KG. FURTHERMORE, THE NAIL WAS INSERTED IN RETROGRADE INSTEAD OF ANTEGRADE. ANTEROGRADE INSERTION IS THE PREFERRED APPROACH IN PATIENTS WITH PROXIMAL FRACTURES SUCH AS THIS CASE SINCE IT MAXIMIZES THE RESISTANCE PROXIMALLY WHERE IT IS MOST NEEDED. RETROGRADE INSERTION PLACES THE WEAKEST SECTION OF THE NAIL (THE TIP OF THE NAIL) PROXIMALLY WHERE THE HIGHEST LOADS ARE EXPERIENCED DUE TO THE PROXIMITY OF THE FRACTURE OR OSTEOTOMY AND THE LEVER ARM OF THE HIP. THE SURGEON HAD NO CHOICE BUT TO INSERT THE NAIL IN RETROGRADE DUE TO SPECIFIC PATIENT CONDITIONS (DISTAL OSTEOTOMY). THE COMBINATION OF HIGH LOADS DUE TO THE PATIENT BEING OVERWEIGHT AND THE RETROGRADE INSERTION, CAUSED THE NAIL TO FAIL PROXIMALLY AT THE DISTAL LOCKING SCREW HOLE. THE BROKEN NAIL HAS BEEN SUCCESSFULLY RETRIEVED AND REPLACED FOR ANOTHER NAIL WITH A LARGER DIAMETER.

    Description of Event or Problem · 1

    A GAP-N56-28 NAIL WAS USED IN A (B)(6) YEAR-OLD OVERWEIGHT PATIENT TO CORRECT A VALGUS DEFORMITY. THE NAIL WAS INSERTED IN RETROGRADE FOLLOWING OSTEOTOMY AND CORRECTION OF THE RIGHT FEMUR. THREE WEEKS POST-SURGERY THE NAIL FAILED PROXIMALLY, SPECIFICALLY AT THE DISTAL SCREW HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803610 GAP ENDO-EXO MEDULLARY SYSTEM INTRAMEDULLARY NAIL HSB PEGA MEDICAL, INC. 121218-010

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention