BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3234210 · Received July 18, 2013

    Report

    Report Number
    1220246-2013-00126
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE 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 OR APPLYING EXCESSIVE FORCE TO THE SCREW DURING IMPLANTATION. 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. FACILITY WILL NOT RETURN THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCAPHOLUNATE LIGAMENT STABILIZATION, THE TIP OF THE INSERTERS BROKE OFF DURING INSERTION. THE FRAGMENTS OF THE FIRST DEVICE WERE COMPLETELY REMOVED. THE FRAGMENTS OF THE SECOND DEVICE REMAINED INSIDE THE SCREW AND COULD NOT BE REMOVED. PROCEDURE COMPLETED SUCCESSFULLY WITHOUT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335855 BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM SCREW, FIXATION, BONE HWC ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other