BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 23262150 · Received October 9, 2025

    Report

    Report Number
    3000327445-2024-00005
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    October 22, 2024
    Report Date
    October 9, 2025
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    LXH
    PMA / PMN Number
    K111232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE PART WAS RETURNED FROM THE HOSPITAL, RECEIVED AT ORTHOGERIATRICS CANADA, AND INVESTIGATED, IT WAS OBSERVED THAT ITS SHAPE WAS DEFORMED. SPECIFICALLY, THE INSTRUMENT WAS NO LONGER STRAIGHT AND EXHIBITED A SLIGHT CURVATURE. A REVIEW OF THE PRODUCTION RECORDS AND USAGE HISTORY REVEALED THAT THE INSTRUMENT BELONGS TO A RENTAL TRAY ASSEMBLED IN (B)(6) 2013 AND HAD BEEN IN USE SINCE THEN. NO OTHER COMPLAINTS HAD BEEN REPORTED FOR THIS INSTRUMENT PRIOR TO THIS INCIDENT. THE PRODUCTION FOLDER SHOWED ONE NON-CONFORMITY DURING THE INCOMING INSPECTION; HOWEVER, THIS WAS RELATED TO A DIFFERENT ISSUE, WHICH WAS SUCCESSFULLY REWORKED AND RELEASED. AFTER INTERNAL INVESTIGATION AND ASSESSMENT, IT WAS CONCLUDED THAT THE ISSUE MOST LIKELY RESULTED FROM THE INSTRUMENT'S AGE, HAVING BEEN IN USE FOR OVER 10 YEARS, COMBINED WITH REPEATED HIGH-TEMPERATURE STERILIZATION CYCLES IN HOSPITALS. THESE CYCLES GRADUALLY DEGRADED THE MATERIAL AND AFFECTED ITS SHAPE. IT IS IMPORTANT TO NOTE THAT MISALIGNMENT IS COMMON WITH THIS TYPE OF DEVICE, EVEN WHEN FULLY CONFORMING. DURING SURGERY, FACTORS SUCH AS PATIENT WEIGHT, IMPLANT BENDING, AND INSTALLATION FORCE OFTEN CAUSE SLIGHT MISALIGNMENT OF TARGETING DEVICES. IN MOST CASES, THIS CAN BE RESOLVED WITH SLIGHT PRESSURE OR ADJUSTMENTS, ALLOWING THE SURGERY TO PROCEED SUCCESSFULLY WITH THE SAME DEVICE. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR # ON NOVEMBER 21, 2024, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE SUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (3000327445). CAPA INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    THE GAP DISTAL ATTACHMENT WAS MISALIGNED, PREVENTING ITS USE FOR CORTICAL SCREW HOLE ALIGNMENT. THIS CAUSED A DELAY GREATER THAN 30 MINUTES AS THE SURGEON SWITCHED TO THE PERFECT CIRCLE TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704300 GAP ENDO-EXO MEDULLARY SYSTEM GAP DISTAL ATTACHMENT LXH PEGA MEDICAL, INC. J083415-003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other