BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 24642445 · Received March 19, 2026

    Report

    Report Number
    3000327445-2026-00003
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC
    Product Code
    HSB
    PMA / PMN Number
    K111232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR FROM SWITZERLAND REPORTED THAT A GAP NAIL BROKE IN PATIENT. FOLLOWING FURTHER DISCUSSION BETWEEN THE DISTRIBUTOR AND THE TREATING SURGEON, PROF. (B)(6), ADDITIONAL INFORMATION BECAME AVAILABLE. ACCORDING TO PROF. (B)(6), THE MOST LIKELY CAUSE OF THE NAIL BREAKAGE WAS PATIENT RELATED BIOLOGICAL FACTORS (CHILD'S BIOLOGY), RATHER THAN A DEVICE-RELATED ISSUE. BASED ON THIS ASSESSMENT, THE SURGEON INDICATED THAT HE DOES NOT INTEND TO FILE AN EXTERNAL REPORT RELATED TO THIS EVENT. THE IMPLANT WAS SCHEDULED TO BE REMOVED ON (B)(6) DURING REVISION SURGERY AND REPLACED WITH A NEW GAP NAIL. THE DISTRIBUTOR CONFIRMED THAT, FOLLOWING EXPLANTATION, THE REMOVED NAIL WILL BE RETURNED TO ORTHOPEDIATRICS FOR EXAMINATION. THIS RETURN WILL ALLOW FOR A DEVICE-LEVEL ASSESSMENT, IF DEEMED NECESSARY. AT THE TIME OF THIS INVESTIGATION, NO DETAILED CLINICAL OR PROCEDURAL INFORMATION (E.G., PATIENT WEIGHT, DURATION OF IMPLANTATION, FRACTURE PATTERN, OR INTRAOPERATIVE OBSERVATIONS) HAD BEEN PROVIDED BEYOND THE SURGEON'S CONCLUSION REGARDING BIOLOGICAL FACTORS. ADDITIONALLY, THE DEVICE HAD NOT YET BEEN RECEIVED FOR ANALYSIS; THEREFORE, NO PHYSICAL EXAMINATION WAS PERFORMED DURING THIS PHASE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A MANUFACTURING DEFECT OR SYSTEMIC PRODUCT ISSUE. THE EVENT IS CURRENTLY CONSIDERED LIKELY ATTRIBUTABLE TO PATIENT-RELATED FACTORS, AS ASSESSED BY THE TREATING SURGEON. NO SIMILAR TRENDS OR SIGNALS RELATED TO GAP NAIL BREAKAGE WERE IDENTIFIED DURING THIS INVESTIGATION. THE CURRENT DESIGN OF THE GAP AIMS TO MINIMIZE THE RISKS FRACTURES IN PATIENTS WITH BONE DYSPLASIAS INVOLVING WEAK AND/OR THIN BONES. IN THESE CASES, THE SIZE OF THE BONE DETERMINES THE MAXIMUM SIZE OF NAIL THAT CAN BE USED. WHILE THE USE OF THE GAP NAIL ALLOWS A DECREASE OF THE PROBABILITY OF BONE FRACTURES, THE SMALL SIZE OF BONE AND ITS WEAKNESS WILL REMAIN AN UNDERLYING CONDITION. THUS, THE POSSIBILITY OF BONE OR NAIL FRACTURE IS STILL EXISTENT. THIS INVESTIGATION IS CONSIDERED CLOSED PENDING RECEIPT OF THE EXPLANTED DEVICE. SHOULD EXAMINATION OF THE RETURNED NAIL IDENTIFY FINDINGS INCONSISTENT WITH CURRENT CONCLUSIONS, THE COMPLAINT WILL BE REOPENED AND REASSESSED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    A GAP NAIL FRACTURED WHILE IMPLANTED IN THE PATIENT. THE BROKEN IMPLANT REMAINS IN SITU. A REVISION SURGERY WILL BE REQUIRED TO REMOVE AND REPLACE THE NAIL. ADDITIONAL INFORMATION WILL BE REQUIRED FROM THE DISTRIBUTOR, INCLUDING THE PATIENT'S WEIGHT, THE SIZE AND LOT NUMBER OF THE FRACTURED NAIL, THE DURATION OF IMPLANTATION, AND ANY AVAILABLE DETAILS REGARDING THE CIRCUMSTANCES UNDER WHICH THE NAIL FAILED.

    Description of Event or Problem · 0

    THE DISTRIBUTOR FROM SWITZERLAND REPORTED THAT A GAP NAIL BROKE IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150690 GAP ENDO-EXO MEDULLARY SYSTEM NAIL Ø6.4MM X 180MM HSB ORTHOPEDIATRICS CANADA ULC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention