BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 23267620 · Received October 10, 2025

    Report

    Report Number
    3000327445-2025-00004
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    July 11, 2025
    Report Date
    October 10, 2025
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC
    Product Code
    HXX
    PMA / PMN Number
    K160545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOSPITAL REPRESENTATIVE REPORTED THAT THE GAP-NDR100 GAP NAIL DRIVER WAS FOUND DISASSEMBLED UPON ARRIVAL, WITH ONE SCREW LOCATED AT THE BOTTOM OF THE INSTRUMENT TRAY AND THE OTHER MISSING. THE SURGERY WAS COMPLETED SUCCESSFULLY, THE SURGICAL TEAM DECIDED TO SWITCH TO AN ALTERNATIVE SYSTEM (SLIM). UPON INVESTIGATION, IT WAS DETERMINED THAT THE INSTRUMENT WAS MANUFACTURED IN 2018 AND HAD BEEN IN USE SINCE THEN. NO OTHER SIMILAR COMPLAINTS WERE RECIVED FOR THIS CATALOG IN THE PAST. THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION; HOWEVER, PHOTOGRAPHS PROVIDED BY THE HOSPITAL SHOW THAT BOTH SCREWS WERE MISSING, WITH ONLY ONE RECOVERED FROM THE TRAY. THERE WAS NO VISIBLE DAMAGE TO THE DRIVER SUGGESTING MECHANICAL FAILURE AS THE CAUSE OF THE SCREWS BECOMING LOOSE. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE IS THAT THE INSTRUMENT WAS NOT PROPERLY INSPECTED PRIOR TO BEING SHIPPED FOR SURGERY BY THE AUSTRALIAN DISTRIBUTOR. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2025-00004 ON AUGUST 8, 2025, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (3000327445). CAPA INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    THE HOSPITAL REPRESENTATIVE REPORTED THAT THE GAP-NDR100 GAP NAIL DRIVER WAS DISASSEMBLED, WITH ONE SCREW FOUND AT THE BOTTOM OF THE INSTRUMENT TRAY AND ANOTHER MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302846 GAP ENDO-EXO MEDULLARY SYSTEM GAP NAIL DRIVER HXX ORTHOPEDIATRICS CANADA ULC A034-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other