BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION COMPRESSON¿ INSTRUMENT

    MDR report key: 23552040 · Received November 14, 2025

    Report

    Report Number
    3003407235-2025-00016
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    October 15, 2025
    Report Date
    October 20, 2025
    Manufacturer
    INION OY
    Product Code
    HWX
    UDI-DI
    06438408008061
    PMA / PMN Number
    K203105
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INVESTIGATION, IT IS CONCLUDED THAT THE Ø 0.8 MM K-WIRE (NON-INION DEVICE) HAS NOT BEEN ABLE TO HOLD ITS ALIGNMENT DURING DRILLING AND HAS GOT STUCK IN THE BONE CHANNEL IN AN OBLIQUE POSITION. WHILE DRILLING THE INION DRILL TAP OVER THE K-WIRE, THE PART OF THE K-WIRE INSIDE THE DRILL TAP CANNULA HAS STARTED TO REVOLVE WITH THE DRILL TAP INSTRUMENT WHILST THE BENT TIP OF THE K-WIRE HAS STAYED STATIONARY AND HAS BEEN TWISTED AND SNAPPED BROKEN. AT THE SAME TIME, THE CUTTING EDGES OF THE TIP OF THE DRILL TAP HAVE GRINDED AGAINST THE BENT K-WIRE AND PARTIALLY BROKEN OFF. BASED ON DESIGN ENGINEER EVALUATION, THE DRILL TAP BROKE DUE TO K-WIRES BEING POSITIONED OBLIQUELY WITHIN THE BONE CANALS, WHICH EVENTUALLY CAUSED THE DRILL TAP TIP BREAKAGE.

    Description of Event or Problem · 0

    DURING A KNEE OCD FIXATION, AFTER THE INSERTION OF THE FIRST K-WIRE, INION DRILL TAP BROKE AT ITS TIP. THIS WAS NOTICED AFTER THE INSERTION OF THE SECOND K-WIRE, WHEN THE DRILL TAP BECAME MORE TIGHTLY STUCK. UPON TAKING THE DRILL TAP OUT, IT WAS DISCOVERED THAT THE K-WIRE HAD BROKEN INSIDE THE BONE. AT THIS POINT THE FIRST K-WIRE WAS ALSO CHECKED (SCREW WAS ALREADY INSERTED) AND IT WAS DISCOVERED THAT THE FIRST K-WIRE HAD ALSO BEEN BROKEN INSIDE THE BONE. THE BROKEN K-WIRE PIECES WERE REMOVED FROM POSTERIOR (POPLITEAL) SIDE, WHICH ADDED 60 MINUTES TO THE OPERATION TIME. A SMALL PIECE OF THE DRILL TAP TIP (APPROXIMATELY 1MM) WAS LEFT INSIDE THE FIRST SCREW TUNNEL. BASED ON SURGEON'S EVALUATION, THE ONLY HARM TO PATIENT CAUSED BY THE INCIDENT WAS AN ADDITIONAL SURGICAL SCAR TO POPLITEAL SIDE. THIS EVENT IS BEING REPORTED AS IT CAUSED APPROXIMATELY A 60-MINUTE DELAY TO OPERATION TIME AND THE REMOVAL OF THE BROKEN K-WIRE PIECES FROM THE POPLITEAL SIDE CAUSED A CHANGE IN THE ORIGINAL OPERATION PLAN AND RESULTED IN AN ADDITIONAL SURGICAL SCAR TO POPLITEAL AREA. ALSO THE INION DRILL TAP BROKE DURING OPERATION AND A SMALL PIECE FROM THE DRILL TAP TIP WAS LEFT INSIDE THE SCREW TUNNEL. NOTE: THE K-WIRE USED WITH THE DRILL TAP WAS NOT MANUFACTURED BY INION. ACCORDING TO INION'S INSTRUCTIONS FOR USE ONLY INION K-WIRES SHOULD BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249437 INION COMPRESSON¿ INSTRUMENT BONE TAP, REUSABLE HWX INION OY 1 231017 06438408008061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention K-WIRES (NOT MANUFACTURED BY INION).