BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL NAIL, STANDARD T2 TIBIA Ø12X330 MM

    MDR report key: 21787189 · Received April 7, 2025

    Report

    Report Number
    0008031020-2025-00668
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 11, 2025
    Report Date
    June 18, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE REFER TO SECTIONS D9 (THE DEVICE WAS RETURNED) AND H6 (METHOD, RESULTS, CONCLUSION AND HEALTH IMPACT CODES). THE REPORTED EVENT COULD BE CONFIRMED DURING THE INVESTIGATION. NOTE: THE DEVICE WAS ORIGINALLY MANUFACTURED AS K05E331 AND UNDERWENT A RE-STERILIZATION (PERFORMED BY STRYKER) IN 2022. AS A RESULT "RB" WAS ADDED TO THE ORIGINAL LOT NUMBER ON THE DEVICE'S LABEL. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE IDENTIFICATION OF THE RETURNED NAIL COULD BE CONFIRMED BASED ON THE CATALOG # AND THE LOT # MARKED. AS REPORTED, THE NAIL WAS RETURNED ASSEMBLED WITH THE NAIL HANDLE AND THE NAIL HOLDING SCREW. THE ASSEMBLING WAS BLOCKED AND THE DEVICES COULD ONLY BE DISASSEMBLED WITH GREAT EFFORT BY USING OIL AND APPROPRIATE TOOLS. NO DAMAGE WAS OBSERVED ON THE THREADS OF THE NAIL. THEREFORE, IT COULD BE CONFIRMED THAT THE INCIDENT WAS NOT CAUSED BY ANY ISSUE RELATED TO THE NAIL. THE RETURNED NAIL WAS TESTED WITH A FULLY FUNCTIONAL NAIL HOLDING SCREW SAMPLE. THE SCREW COULD BE TIGHTENED TO THE NAIL WITHOUT ANY ISSUE. THIS CONFIRMS THAT THE NAIL IS FULLY FUNCTIONAL AND THAT IT DID NOT CAUSE THE DISASSEMBLING ISSUE. IT WAS OBSERVED DURING THE INSPECTION OF THE NAIL HOLDING SCREW THAT THE INSTRUMENT IS HIGHLY WORN OUT, WHICH CAUSED LOCAL ACCUMULATION OF MATERIAL AND LOCAL THICKENING. AS A RESULT, THE NAIL HOLDING SCREW WAS STUCK INSIDE THE NAIL HANDLE. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO AN USER RELATED ISSUE. HCP IS UNLIKELY TO HAVE INSPECTED AND TESTED THE DEVICES PROPERLY BEFORE THE OPERATION, WHICH EXPLAINS WHY THE WEAR ON THE NAIL HOLDING SCREW WENT UNNOTICED. IN ADDITION, THERE IS EVIDENCE THAT THE USER FORCED THE ASSEMBLY DESPITE THE FACT THAT IT WAS MUCH MORE DIFFICULT THAN USUAL, MAKING IT IMPOSSIBLE TO BE DISASSEMBLED BY NORMAL MEANS. AS A REMINDER, THE INSTRUCTIONS FOR USER CLEARLY STATE THAT: "ENSURE THAT ALL COMPONENTS NEEDED FOR THE OPERATION ARE AVAILABLE IN THE OPERATION THEATRE. INSPECTION IS RECOMMENDED PRIOR TO SURGERY TO DETERMINE IF INSTRUMENTS OR IMPLANTS HAVE BEEN DAMAGED DURING STORAGE OR PRIOR PROCEDURES." A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "INTRAOPERATIVELY, THE NAIL RETAINING PIN (1806-0370) COULD NO LONGER BE DETACHED FROM THE NAIL. THIS MEANT THAT THERE WAS A NON-DETACHABLE CONNECTION BETWEEN THE NAIL RETAINING PIN, THE NAIL ADAPTER (1806-10020) AND THE NAIL ITSELF. THE OPERATION HAD TO BE CONTINUED WITHOUT THE TARGETING DEVICE AND WAS COMPLETED MANUALLY. OPERATION TIME EXTENDED (90 MIN), INCREASED RADIATION DUE TO HANDS-FREE LOCKING."

    Description of Event or Problem · 0

    AS REPORTED: "INTRAOPERATIVELY, THE NAIL RETAINING PIN (1806-0370) COULD NO LONGER BE DETACHED FROM THE NAIL. THIS MEANT THAT THERE WAS A NON-DETACHABLE CONNECTION BETWEEN THE NAIL RETAINING PIN, THE NAIL ADAPTER 1806-1002) AND THE NAIL ITSELF. THE OPERATION HAD TO BE CONTINUED WITHOUT THE TARGETING DEVICE AND WAS COMPLETED MANUALLY. OP TIME EXTENDED (90 MIN), INCREASED RADIATION DUE TO HANDS-FREE LOCKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846663 TIBIAL NAIL, STANDARD T2 TIBIA Ø12X330 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH K05E331RB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown