BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED SCREWDRIVER FOR DELTA BIO-INT SCREW

    MDR report key: 2222360 · Received August 25, 2011

    Report

    Report Number
    1220246-2011-00149
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    June 9, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    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 REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINANT'S EVENT TYPICALLY CAUSED BY OVER-INSERTION, NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL, PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED OR FLEXING THE JOINT WITH THE DRIVER STILL ENGAGED WITH THE SCREW. ALSO THE DFU STATES THAT WHEN INSERTING IN HARD BONE FIRST USE THE PUNCH TO CREATE A PILOT HOLE THEN INSERT THE TAP TO BETTER PREPARE THE BONE. 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 HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF INSIDE A DELTA SCREW THAT WAS BEING INSERTED FOR A TIBIAL IMPLANTATION. THE BROKEN SCREWDRIVER TIP STAYED INSIDE THE SCREW, AND INSIDE PATIENTS KNEE. THE SCREW WAS IMPLANTED ON FEMORAL SIDE. SURGERY WAS DELAYED OVER 30 MIN, IT WAS COMPLETED AND THERE WAS NO SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SCREWDRIVER FOR DELTA BIO-INT SCREW ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 401025106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other