BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNANAIL

    MDR report key: 25342859 · Received May 31, 2026

    Report

    Report Number
    3007593722-2026-00004
    Event Type
    Injury
    Date Received
    May 31, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 30, 2026
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    JDR
    UDI-DI
    M970300010241614120
    PMA / PMN Number
    K220812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STAPLE WOULDN'T DEPLOY OFF THE HANDLE IN CASE. BONE FRACTURED TRYING TO IMPLANT. WAS ABLE TO USE GRAFT AND UPSIZE THE IMPLANT AND IT WORKED FINE. THIS COMPLAINT WAS OPENED UP IN RESPONSE TO A REPORT OF A DYNACLIP DELTA STAPLE THAT HAD DIFFICULTY DEPLOYING. REPORTEDLY, THE STAPLE HAD DIFFICULTY REMOVING FROM THE HANDLE AND CONSEQUENTLY, BONE FRACTURED TRYING TO IMPLANT. THE SURGEON WAS ABLE TO USE GRAFT AND UPSIZE THE IMPLANT AND THE SURGERY WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH NO SIGNIFICANT DELAY. PREVIOUSLY, CAR-00859 WAS INITIATED TO INVESTIGATE AND REMEDY THE CURRENT ISSUE OF THE DYNCALIP STAPLES HAVING DIFFICULTY DEPLOYING. HHE-00071 WAS ALSO OPENED TO INVESTIGATE FIELD INVENTORY. THE MAIN CHANGE IMPLEMENTED FROM THE CAPA WAS REMOVING THE MANDATORY USE OF THE ARBOR PRESS IN MANUFACTURING. THIS WAS IMPLEMENTED 5/20/2025 AND MONITORED FOR EFFECTIVENESS THROUGH 01/26/2026, IN WHICH, THE CHANGES WERE DEEMED SUCCESSFUL AND THE CAPA WAS CLOSED. THE DYNACLIP RISK MATRIX RISK-FA005-001 REV A. (ED-50260 RISK MANAGEMENT DOCUMENT-DESIGN, DYNACLIP, REV 10), WAS REVIEWED. IN THE RISK MATRIX, 'DIFFICULTY RELEASING STAPLE AFTER SUCCESSFUL INSERTION WAS ACCOUNTED FOR, THE RISK WAS RANKED A SCORE OF DETECTION 3, SEVERITY 3 AND OCCURRENCE 1. THE POTENTIAL EFFECTS OF THE FAILURE OCCURRENCE ARE THE NEED TO REPLACE THE STAPLE, A PROCEDURAL DELAY AND SURGEON HASSLE. THIS RISK SEVERITY WAS RATED 3 PER LEGACY QS-7.1-08, RISK MANAGEMENT BECAUSE DIFFICULTY DISENGAGING THE INSERTER FROM THE STAPLE HAS THE WORST-CASE POTENTIAL OF CAUSING PATIENT HARM THROUGH LOSS OF FUNCTION OR REVISION SURGERY. THIS IS THE FIRST OCCURRENCE OF THIS DEFECT TO THE PRODUCT FAMILY SINCE THE IMPLEMENTATION VERIFICATION TO BE REPORTED. THE HAZARD IS AN ANTICIPATED RISK WITHIN THE RISK ANALYSIS MATRIX AND A SINGLE OCCURRENCE IS NOT AN INDICATION OF A SYSTEMATIC ISSUE NECESSITATING A CAPA INVESTIGATION. THEREFORE, NO FURTHER ACTION IS NEEDED BUT WILL CONTINUED TO BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED STAPLE WOULDN'T DEPLOY OFF THE HANDLE IN CASE. BONE FRACTURED TRYING TO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352634 DYNANAIL DELTA DYNACLIP STAPLE, 24X16X14X12 JDR MEDSHAPE, INC. 32269 M970300010241614120

    Patients

    Seq Age Sex Outcome Treatment
    1