BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREADED GUIDE WIRE W/ TROCAR TIP, DIA 1.35MM

    MDR report key: 2190532 · Received August 4, 2011

    Report

    Report Number
    1220246-2011-00118
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT PART REMAINS IN THE PATIENT AND CANNOT BE RETURNED THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE MOSTLY LIKELY CAUSES OF THE K-WIRE BREAKING IS DUE TO NOT FOLLOWING THE PROPER TECHNIQUE AND PRYING/LEVERAGING OF THE K-WIRE. LOT NUMBER WAS REQUESTED BUT NOT PROVIDED; THEREFORE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED... THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE THREADED TIPS OF THE 2 K-WIRES BROKE ON INSERTION DURING ANKLE FRACTURE REPAIR,(TIPS NOT RETRIEVED). A 2.6 DRILL WAS USED FOR TUNNEL PREP PRIOR TO INSERTION. THREADED TIPS ARE DEEP IN THE BONE AND WOULD NOT RELEASE AS SURGEON TRIED TO REMOVE THE WIRES, BOTH OF THE IMPLANTS WERE LEFT IN PLACE AND ARE OVERTOP OF THE BROKEN TIP PIN. SURGEON USED A SIDE TO SIDE MOTION WHILE TRYING TO REMOVE THE WIRES. BONE QUALITY HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THREADED GUIDE WIRE W/ TROCAR TIP, DIA 1.35MM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other