BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSITCP 30 INTERFERENCE SCREW 9MM X 25MM

    MDR report key: 2200239 · Received August 11, 2011

    Report

    Report Number
    1825034-2011-00693
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Product Code
    HWC
    PMA / PMN Number
    K090994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE FOUND THE PRODUCT TO BE ASYMMETRIC. THE SCREW APPEARS TO HAVE BEEN FLATTENED, BUT THERE IS NO EVIDENCE OF SURFACE DAMAGE ON THE SCREW. THE LACK OF ABRASIONS OR SIGNS OF FORCE SUGGESTS THE DAMAGE OCCURRED DURING THE MOLDING / MANUFACTURING PROCESS WHILE THE SCREW WAS STILL MALLEABLE. THE SCREW HAS BEEN FORWARDED TO THE SUPPLIER FOR FURTHER EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ACL PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO IMPLANT AN INTERFERENCE SCREW BUT THE SCREWDRIVER WOULD NOT MATE WITH THE SCREW. THE INDENTATIONS IN THE HEAD OF THE SCREW APPEARED TO BE OFF-CENTER. THE PROCEDURE WAS COMPLETED USING ANOTHER SCREW THAT WAS ON HAND. NO PATIENT INJURY OR DELAY IN THE PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSITCP 30 INTERFERENCE SCREW 9MM X 25MM SCREW, FIXATION HWC BIOMET SPORTS MEDICINE, INC. N/A 110097

    Patients

    Seq Age Sex Outcome Treatment
    1