BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3791908 · Received May 6, 2014

    Report

    Report Number
    1220246-2014-00070
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 11, 2014
    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/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE COMPLAINANT'S EVENT IS TYPICALLY CAUSED BY NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL, PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED AND/OR IMPROPER BONE PREPARATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE EXPECTED BUT NOT YET RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, DURING A HAND PROCEDURE THE DRIVER BROKE ON INSERTION ON THE IMPLANT INTO THE FINGER. THE SCREWDRIVER'S HEX BROKE OFF AT THE LAST TURN AND HAD TO BE LEFT INSIDE THE SCREW, WHICH REMAINS IMPLANTED IN PATIENT. SURGERY OUTCOME OK. NO FURTHER EVENT DETAILS GIVEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272361 BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM SCREW, FIXATION, BONE HWC ARTHREX, INC. 823088

    Patients

    Seq Age Sex Outcome Treatment
    1 Other