BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM

    MDR report key: 2498779 · Received March 21, 2012

    Report

    Report Number
    1220246-2012-00047
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 1, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    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 WAS NOT 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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE FLEXING THE JOINT DURING INSERTION OF THE IMPLANT WITH THE DRIVER ENGAGED, PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED, PREPARING A PILOT HOLE THAT IS TOO SMALL, INSERTING THE IMPLANT AT AN ANGLE NOT CO-AXIAL TO THE PILOT HOLE, INCORRECT DRIVER AND SCREW COMBINATION, OR APPLYING EXCESSIVE FORCE TO THE SCREW DURING IMPLANTATION. THIS IS THE SECOND COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN X-RAY WAS DONE AFTER IMPLANTS WERE SEATED IN THE DRILL TUNNELS WHEREAS IT WAS OBSERVED THAT A DEVICE FRAGMENT WAS IN THE BONE TUNNEL OF THE METACARPAL BENEATH THE IMPLANT. IT WAS THEN NOTICED THAT THE DISTAL TIP OF THE DRIVER WAS MISSING. THIS WAS A RECONSTRUCTION OF A THUMB UCL UTILIZING THE 3X8 TENODESIS TECHNIQUE. THE PATIENT IS DOING WELL AND THERE ARE NO PLANS FOR A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM SCREW, FIXATION, BONE HWC ARTHREX, INC. 322875

    Patients

    Seq Age Sex Outcome Treatment
    1 Other