BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1561705 · Received December 18, 2009

    Report

    Report Number
    1220246-2009-00229
    Event Type
    Injury
    Date Received
    December 18, 2009
    Date of Event
    November 19, 2009
    Report Date
    November 30, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP COMMUNICATION WITH THE EVENT REPORTED PROVIDED ADDITIONAL INFORMATION THAT THE TIP OF THE DRIVER BROKE WHILE THE SURGEON WAS INSERTING THE SCREW; SCREW IS FLUSH WITH THE BONE. ACCORDING TO THE REPORTER, THE SURGEON USED A 2.8 MM DRILL BIT TO PREP A BONE TUNNEL FOR A 3 X 8 MM SCREW; BONE TUNNEL WAS POSSIBLY TOO SMALL FOR THIS SIZE SCREW AND A GRAFT. PATIENT'S DEMOGRAPHICS (DATE OF BIRTH AND 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.BASED ON THE INFORMATION PROVIDED, AS REPORTED, THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS PREPARING A PILOT HOLE THAT IS TOO SMALL. A PILOT HOLE THAT IS TOO SMALL MAY COMPRESS THE IMPLANT AROUND THE DRIVER CREATING DIFFICULTY REMOVING THE DRIVER FROM THE SCREW HEAD.THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. 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

    IT WAS REPORTED THAT DURING A THUMB UCL REPAIR THE TIP OF THE DRIVER BROKE INSIDE THE SCREW AND REMAINS IN THE PATIENT. ACCORDING TO THE EVENT REPORTER, THE DOCTOR USED A 2.8MM DRILL BIT TO PREPARE THE BONE TUNNEL. THE SURGEON TRIED TO RETRIEVE THE BROKEN TIP AND WAS UNABLE; SECURE INSIDE SCREW. PATIENT¿S QUALITY OF BONE WAS REPORTED AS GOOD. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TENODESIS SCREW WITH HANDLE INSERTER, 3 X 8MM SCREW, FIXATION, BONE HWC ARTHREX, INC. 253140

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other