BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 6771486 · Received August 7, 2017

    Report

    Report Number
    3000327445-2017-00003
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    July 11, 2017
    Report Date
    July 28, 2017
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    HSB
    PMA / PMN Number
    K160545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS THE FIRST TIME THIS SURGEON USES THE GAP SYSTEM. THE REPRESENTATIVE PRESENT AT THE SURGERY INDICATED THAT THE CANAL WAS PREPARED FOR A Ø4.8 MM NAIL, BUT A Ø5.6 MM NAIL WAS FINALLY IMPLANTED. CONSEQUENTLY, SIGNIFICANT DOWNWARDS PRESSURE HAD TO BE APPLIED TO THREAD THE NAIL IN PLACE, HOWEVER, NO IMPACTION WAS NECESSARY. THE REPRESENTATIVE MENTIONED THAT THE SURGEON USED BOTH HANDS ON THE INSTRUMENT TO INSERT THE NAIL. IT IS POSSIBLE THAT THE SURGEON INADVERTENTLY UNSCREWED OR OVER-TIGHTENED THE BARREL INDUCING UNDUE EFFORTS INTO THE THREADED SHAFT. THE REPRESENTATIVE ALSO INDICATED THAT IT WAS HARD TO UNSCREW THE NAIL DRIVER FROM THE NAIL. THE BARREL WAS ROTATED FOR A LONG TIME BUT THE DRIVER WAS NOT UNTHREADING. THE NAIL DRIVER WAS EVENTUALLY REMOVED BY PULLING IT OUT WITHOUT IMPACTION; HOWEVER THE TIP OF THE DRIVER WAS BROKEN. THE SURGERY WAS SUCCESSFULLY COMPLETED BUT THE BROKEN PIECE REMAINED IN THE PATIENT.

    Description of Event or Problem · 1

    THE THREADED TIP OF THE GAP NAIL DRIVER INSTRUMENT BROKE. THE FAILURE WAS DETECTED DURING THE REMOVAL OF THE INSTRUMENT AT THE END OF THE SURGERY. THE GAP NAIL DRIVER IS AN INSTRUMENT USED FOR THE INSERTION OF THE IMPLANTABLE GAP ENDO-EXO MEDULLARY SYSTEM IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552218 GAP ENDO-EXO MEDULLARY SYSTEM INTRAMEDULLARY NAIL, HSB PEGA MEDICAL, INC. 110922-052

    Patients

    Seq Age Sex Outcome Treatment
    1 Other