BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 23268640 · Received October 10, 2025

    Report

    Report Number
    3000327445-2023-00002
    Event Type
    Injury
    Date Received
    October 10, 2025
    Report Date
    October 10, 2025
    Manufacturer
    PEGA MEDICAL INC
    Product Code
    HSB
    PMA / PMN Number
    K111232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE Ø6.4MM GAP NAIL WAS FOUND BROKEN DURING PATIENT FOLLOW-UP AFTER 3.5 YEARS OF IMPLANTATION. PEGA MEDICAL WAS INFORMED OF THIS FAILURE ON (B)(6) 2023. THE PATIENT SUFFERED FROM OSTEOGENESIS IMPERFECTA. A COXA-VARA PLATE WAS USED WITH K-WIRES IN THE INITIAL SURGERY MOST LIKELY TO CORRECT A VARUS DEFORMATION OF THE FEMORAL HEAD. INFORMATION PROVIDED BY THE COMPANY REPRESENTATIVE INDICATED THAT THE GAP NAIL WAS IMPLANTED WHEN THE PATIENT WAS 4.5 YEARS OLD. THE NAIL WAS FOUND BROKEN 3.5 YEARS AFTER (PATIENT 8 YEARS-OLD). THE PATIENT WEIGHT WAS 22.8KG AT THAT TIME. THE X-RAY (FIGURE 1) SHOWS THAT THE FAILURE OCCURRED AT THE LEVEL OF THE FIRST DISTAL HOLE. THE BONE DID NOT PRESENT ANY DIAPHYSEAL FAILURE OR AT THE FEMORAL HEAD. HOWEVER, THE POSITION OF THE WIRES AND THE PLATE AS WELL AS THE ANGLE MEASUREMENT SHOWN IN THE X-RAY INDICATE THAT SOME VARUS DEFORMATION WAS STILL PRESENTED AFTER 3.5 YEARS OF IMPLANTATION. CONSIDERING THAT THE FAILURE WAS FOUND AFTER 3.5 YEARS OF IMPLANTATION AND THERE WAS NOT DIAPHYSEAL BONE FAILURE, IT IS LIKELY THAT THE NAIL BROKE DUE TO FATIGUE. A PLAUSIBLE HYPOTHESIS WOULD BE THAT, AFTER SURGICAL CORRECTION OF THE COXA-VARA, THE VARUS DEFORMATION WAS GRADUALLY PROGRESSING DURING THE IMPLANTATION AS PATIENT RESUMED TO ITS NORMAL DAILY ACTIVITIES. WITH THE PROGRESSION OF THE COXA-VARA, THE NAIL WAS SUBMITTED TO INCREASINGLY HIGHER CYCLIC LOADS UNTIL FAILURE OCCURRED. DUE TO THE BIOMECHANISM OF THE FEMUR, STRESSES ARE NORMALLY HIGHER AT MID-SHAFT OF THE BONE. ALTHOUGH THE INITIAL POSITION OF THE NAIL IS UNKNOWN SINCE BONE GROWTH OCCURRED DURING THE 3.5 YEARS OF IMPLANTATION, THE FACT THAT THE DISTAL SECTION OF THE NAIL WAS PLACED AT THE MID-SHAFT MOST LIKELY CONTRIBUTED TO THE FAILURE. THUS, IT IS POSSIBLE THAT A LONGER NAIL COULD HAVE BETTER RESISTED TO THE FATIGUE STRESSES SINCE THOSE STRESSES WOULD HAVE BEEN APPLIED AT THE LEVEL OF THE SHAFT OF THE NAIL RATHER THAN THE DISTAL SECTION WITH THE HOLES. NEVERTHELESS, IT IS ALSO POSSIBLE THAT THE LONGEST NAIL FOR THE BONE WAS INITIALLY USED, AND SIGNIFICANT BONE GROWTH OCCURRED. REVIEW OF HISTORY OF REPORTED GAP NAIL FAILURES SHOWS THAT THERE HAS BEEN OTHER DISTAL FAILURES OF GAP NAILS IN PATIENTS. THESE FAILURES WERE ONLY REPORTED FOR THE 4.8MM AND 5.6MM DIAMETER NAILS. FAILURES OF THE 4.8MM NAIL WERE NOT REPORTED AFTER REDUCTION OF THE DISTAL HOLE IN 2016. FOUR FAILURES WERE REPORTED FOR 5.6MM NAILS, TWO OF THEM WERE DUE TO PATIENT OVERWEIGHT, ONE DUE TO PATIENT WEIGHT BEARING BEFORE COMPLETE BONE CONSOLIDATION AND THE LAST ONE DUE TO FATIGUE FAILURE AFTER 5 YEARS OF IMPLANTATION. THUS, THIS IS THE FIRST TIME THAT A FAILURE OF A 6.4MM DIAMETER GAP NAIL IS REPORTED. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR # 3000327-2023-00002 ON MARCH 30, 2023, 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

    6.4MM DIAMETER GAP NAIL WAS FOUND BROKEN IN THE PATIENT AT THE LEVEL OF THE FIRST DISTAL HOLE AFTER 3 1/2 YEARS OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488530 GAP ENDO-EXO MEDULLARY SYSTEM GAP NAIL HSB PEGA MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Unknown Other