BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORX T8 ATTACHMENT SCREWDRIVER

    MDR report key: 9154948 · Received October 4, 2019

    Report

    Report Number
    3010470577-2019-09181
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    August 6, 2019
    Report Date
    October 3, 2019
    Manufacturer
    IN2BONES SAS
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RISK ASSESSMENT WAS CONDUCTED THANKS TO BOTH THE RAW MATERIAL COMPOSITION OF THE SCREWDRIVER AND LITERATURE ANALYSIS OF TOXICOLOGICAL EFFECTS OF ITS VARIOUS COMPOUNDS (SI, MN, NI, CR,S, P, C), USING A WORST-CASE APPROACH FOR THE CALCULATION OF THE SIZE OF THE IMPLANTED PIECE (THICKNESS AND SURFACE MAXIMIZED COMPARED TO REAL PART) AND THE SIZE OF THE HUMAN BODY IN WHICH IT WAS IMPLANTED (ASSESSMENT BASED ON A 50KG PATIENT, I.E. A SMALL STATURE PERSON). IT WAS CONCLUDED THAT THE IMPLANTED PIECE HAS A VERY LOW RISK OF CORROSION (PASSIVATED LAYER). AND EVEN IF IT WERE TO BE FULLY CORRODED, THE PIECE IS NOT LIKELY TO INDUCE ANY TOXICOLOGICAL REACTION DUE TO THE LOW QUANTITY OF COMPOUNDS HYPOTHETICALLY RELEASED INTO THE BODY (SAFETY RATIOS BETWEEN 9 AND 95000 DEPENDING UPON THE COMPOUNDS). IN ADDITION, THE RISK OF MIGRATION OF THE PIECE OF SCREWDRIVER IS JUDGED REMOTE, SINCE IT IS STUCK IN THE IMPLANTABLE OSTEOSYNTHESIS SCREW HEAD, WITH TIGHT TOLERANCES. THIS WAS THE FIRST OCCURRENCE OF THIS DEVICE BREAKAGE RECORDED INTO IN2BONES (B)(4). SUCH EVENTS WILL CONTINUE TO BE MONITORED IN THE FUTURE.

    Description of Event or Problem · 1

    ORTHOPAEDIC FOOT SURGERY. THE SURGEON WAS PERFORMING A LAPIDUS PROCEDURE ON THE FOOT USING COLINK OSTEOSYNTHESIS SCREWS (MANUFACTURED BY IN2BONES USA). AFTER THE SURGERY COMPLETION, THE SURGEON TOOK X-RAYS. UPON VIEWING THE X-RAYS, THE SURGEON FELT THE SCREWS IMPLANTED WERE TOO LONG AND DECIDED TO REMOVE TWO SCREWS AND REPLACE THEM WITH SHORTER SCREWS. THE FIRST SCREW WAS REMOVED USING THE IN2BONES SAS TORX T8 ATTACHMENT SCREWDRIVER WITH NO ISSUE. WHEN THE SURGEON WENT TO REMOVE THE SECOND SCREW (A 3.0X20MM COLINK LOCKING SCREW), THE TIP OF THE SCREWDRIVER BROKE OFF INTO THE SCREW HEAD. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN TIP OF THE SCREWDRIVER FROM THE SCREW HEAD. THE BROKEN TIP OF THE SCREWDRIVER AND THE SCREW REMAINED IN THE PATIENT. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE NONETHELESS. PATIENT OUTCOME: THE PATIENT WAS IMPLANTED WITH A SMALL INSTRUMENT PART (SCREWDRIVER TIP) NOT MEANT TO BE IMPLANTED. THE IMPLANTED PART IS LOCATED INTO AN OSTEOSYNTHESIS SCREW HEAD, AND LOCKED INTO IT WITH A LIMITED RISK OF MIGRATION. NO OTHER CLINICAL CONSEQUENCES REPORTED, AS THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948828 TORX T8 ATTACHMENT SCREWDRIVER TORX T8 ATTACHMENT SCREWDRIVER HXX IN2BONES SAS 1810064/1

    Patients

    Seq Age Sex Outcome Treatment
    1