BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, CANN. DELTA TAPERED BIO-INT. 10MM

    MDR report key: 1984405 · Received February 11, 2011

    Report

    Report Number
    1220246-2011-00026
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K062466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS INCIDENT. COMPLAINT CONFIRMED. THE EVALUATION REVEALED ONE OF THE RETURNED SCREWS TO BE BROKEN IN HALF AT ITS TRANSITION AREA. THE OTHER RETURNED SCREW WAS UNDAMAGED. ALL RELATED MEASURABLE CRITICAL DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATION. BOTH SCREWS WERE FOUND TO ADEQUATELY FIT ON AN (B)(4) DRIVER. 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. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Additional Manufacturer Narrative · 1

    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 NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL OR PRYING/LEVERAGING THE IMPLANT OR IMPROPER BONE PREPARATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT NUMBER COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DELTA SCREW BROKE. THEY TRIED TO RETRIEVE THE SCREW, BUT WASN'T POSSIBLE ANYMORE. TO FINISH THE SURGERY, THE SURGEON STITCHED THE GRAFT ONTO THE PERIOST. THE SCREWDRIVER WAS FULLY SEATED INTO THE SCREW, WHEN THE PROBLEM OCCURRED, ONE PART IS RETURNED FOR INVESTIGATION. THEY WERE NOT ABLE TO RETRIEVE THE OTHER PART ANYMORE. PROCEDURE: ACL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW, CANN. DELTA TAPERED BIO-INT. 10MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 307559

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other