BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE-WIRE DIAM 3.2MM LENGTH 350MM

    MDR report key: 11054302 · Received December 22, 2020

    Report

    Report Number
    3010470577-2011-00171
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 18, 2020
    Manufacturer
    IN2BONES SAS
    Product Code
    FZX
    PMA / PMN Number
    173811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD OF THE KWIRE MANUFACTURED BY IN2BONES WAS REVIEWED AND FOUND TO BE COMPLIANT. AFTER INVESTIGATION, IT WAS FOUND THAT THE ISSUE WAS CAUSED BY DEVICE MISUSE BY THE SURGEON. INDEED, THE FLEXIBLE REAMER (NOT PROVIDED BY IN2BONES; MANUFACTURED BY BOJIN MEDICAL) WAS USED IN CONJUNCTION WITH THE KWIRE BY IN2BONES, WHICH SHOULD NOT HAVE BEEN THE CASE. THE FLEXIBLE REAMERS' IFU, WHICH IS SENT WITH THE DEVICES, STATES THAT "WHEN A BOJIN FLEXIBLE REAMER IS USED, IN THE TIBIA AND FEMUR A OLIVE-TIPPED GUIDE WIRE MUST BE INSERTED FIRST". MOREOVER, THE IFU STATES : "THE INSTRUMENT SHOULD NOT BE FORCED WHEN RESISTANCE IS ENCOUNTERED, AND SHOULD ALWAYS BEEN WITHDRAWN WHEN IT NOT ADVANCING". THIS IS THE FIRST OCCURRENCE OF THE EVENT RECORDED BY IN2BONES, ITS CALCULATED OCCURRENCE IS OF 0,15%.THIS IS CONSIDERED RARE ACCORDING TO IN2BONES STANDARD OPERATING PROCEDURES; THE SEVERITY WAS EVALUATED AS MODERATE, AND THEREFORE, NO FIELD ACTION WAS DEEMED NECESSARY. OTHER ACTIONS INCLUDE: ADDITIONAL TRAINING OF THE DISTRIBUTOR'S TEAM; UPDATE OF THE SURGICAL TECHNIQUE MANUAL TO FURTHER HIGHLIGHT THE FACT THAT ANY FLEXIBLE REAMERS (NOT PROVIDED BY IN2BONES) SHOULD BE USED IN CUNJUNCTION WITH AN OLIVE-TIPPED GUIDE, AS PER THE MANUFACTURER'S SPECIFICATIONS. SHOULD ANY NEW ELEMENT ARISE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED DURING A TIBIOTALOCALCANEAL ARTHRODESIS SURGERY, PERFORMED TO IMPLANT AN INTRAMEDULLARY NAIL IN THE PATIENT'S ANKLE. IN2BONES' (B)(4) DISTRIBUTOR REPORTED THE FOLLOWING NARRATIVE: AFTER THE TIBIO-TALAR JOINT WAS PREPARED (THE SUBTALAR JOINT WAS ALREADY FUSED) A 3.2MM K-WIRE (MANUFACTURED BY IN2BONES SAS) WAS PLACED CENTRALLY UP THE TIBIA THROUGH THE CALCANEUS AND TALUS. A CANNULATED FLEXIBLE REAMER (NOT MANUFACTURED, BUT DISTRIBUTED BY IN2BONES SAS) FOR THE TIBIA WAS USED TO MAKE SPACE FOR THE NAIL TO BE INSERTED. AFTER PLACING THE K-WIRE IN SITU, WHILE THE SURGEON WAS REAMING HE REMARKED IT ENCOUNTERED SOME RESISTANCE, BUT CONTINUED TO REAM. UPON REMOVING THE REAMER IT WAS DISCOVERED THAT THE REAMER HAD ACTUALLY ADVANCED THE K-WIRE UP THE TIBIA AND THROUGH THE INTERCONDYLAR NOTCH INTO THE FEMUR APPROXIMATELY 5 CM. THE SURGEONS WERE UNABLE TO REMOVE THE WIRE FROM ORIGINAL INCISION AT THE ANKLE, TRIED MAKING AN INCISION IN THE KNEE BUT WERE UNSUCCESSFUL AT LOCATING IT. THEY THEN CREATED A SMALL WINDOW IN THE DISTAL TIBIA AND WERE ABLE GRASP THE WIRE AND REMOVE IT. SURGERY PROGRESSED WITHOUT INCIDENT AFTER THIS POINT AND A GOOD SURGICAL OUTCOME WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520484 GUIDE-WIRE DIAM 3.2MM LENGTH 350MM KWIRE FZX IN2BONES SAS N02 00014 1807082

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention