BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EF1

    MDR report key: 21579854 · Received March 11, 2025

    Report

    Report Number
    3007593722-2025-00003
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    February 18, 2025
    Report Date
    July 7, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    KTT
    UDI-DI
    00810028397217
    PMA / PMN Number
    K151580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE POST-OP X-RAY SHOWED A BROKEN 5MM HALF PIN THE TIBIA. DOCTOR EXPLAINED THAT THE MOST PROCIMAL HALF PIN HAD BECOME DETACHED FROM THE FRAME AND PATIENT HAD SUBSEQUENTLY BROKEN THE MOST DISTAL TIBIAL HALF PIN. ALSO, SOMEOF THE NUTS WERE ROUNDED AND CROSS THREADED. HE COMMENTED THAT THE METAL WAS TOO SOFT. THE INVESTIGATION CONFIRMED A TOTAL OF SIX (6) 10MM NUT (DNE-6000-036) WERE COLD WELDING/GALLING TO THE WIRE FIXATION BOLT AND HALF PIN FIXATION BOLT. ONE (1) OF THE 10MM NUTS WAS REMOVED FROM A WIRE FIXATION BOLT AND ADDITIONAL MATERIAL WAS OBSERVED WITHING THE BOLT'S THREADS INDICATING THAT GALLING HAD OCCURRED BETWEEN THE NUT AND BOLT. THIS COMPLAINT WAS REPORTED AFTER A SURGEON REMOVED A CIRCULAR FRAME FROM A PATIENT WHO FELL DOWN THE STAIRS AND BROKE A HALF PIN (DNE-518045). THE HALF PIN BROKE BECAUSE THE FORCES APPLIED DURING THE FALL EXCEEDED THE HALF PIN'S CLINICALLY RELEVANT FORCES. CAR-00916 HAS BEEN OPENED TO FURTHER INVESTIGATE THE 10MM NUT COLD WELDING/GALLING, THIS ALSO LIST ALL THE COMPONENTS RETURNED. NO SIMILAR COMPLAINTS WERE IDENTIFIED WHEN THE COMPLAINTS FOR THE ROLLING YEAR ((B)(6) 2024 THROUGH (B)(6) 2025) WAS REVIEWED FOR ISSUES CONCERNING THE DNE-6000-036, 10MM NUT FOR THE EXTERNAL FIXATION SYSTEMS. THE LOT IS UNKNOWN. THE EF1 CIRCULAR FRAME SURGICAL TECHNIQUE MKT-FA24-0029 REV A WAS REVIEWED. THE 10MM NUTS ARE USED TO SECURE THE MULTIPLE COMPONENTS (I.E. FIXATION BOLTS AND POSTS) TO THE FRAME. THE EF1 RISK MANAGEMENT DOCUMENT RISK-FA007-0001 REV A (MEDSHAPE ED-50572 REV 00) WAS REVIEWED. THE INCLUDED HAZARD ANALYSIS WAS WRITTEN USING SEVERITY, OCCURRENCE, AND DETECTION UNDER THE MEDSHAPE QMS. THIS RISK DOCUMENT DOES NOT COVER THE COLD WELDING/GALLING, IT DOES ASSOCIATE A RISK TO FASTENERS (NUTS, BOLTS) BREAKING OR THREAD STRIPPING WITH A PATIENT SEVERITY 1, DEVICE SEVERITY 1, OCCURRENCE 1 AND DETECTION 1. FOR THE COLD WELDING/ GALLING IT DOES NOT AFFECT THE PATIENT, IT AFFECTS THE SURGEON DURING REMOVAL. A CAR-00916 HAS BEEN OPENED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO POST-OP X-RAY SHOWED A BROKEN 5MM HALF PIN IN THE TIBIA. DOCTOR EXPLAINED THAT THE MOST PROXIMAL HALF PIN HAD BECOME DETACHED FROM THE FRAME AND THE PATIENT HAD SUBSEQUENTLY BROKEN THE MOST DISTAL TIBIAL HALF PIN. ALSO, SOME OF THE NUTS WERE ROUNDED AND CROSS THREADED. HE COMMENTED THAT THE METAL WAS TOO SOFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148500 EF1 NUT - 10MM KTT MEDSHAPE, INC. UNKNOWN 00810028397217

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention DNE-1000-WFB LOT: UNKNOWN.