BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSITCP 30 INTERFERENCE SCREW 7X25MM DUOSORB

    MDR report key: 2231807 · Received September 1, 2011

    Report

    Report Number
    1825034-2011-00774
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HWC
    PMA / PMN Number
    K090994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DRIVE GEOMETRY OF SCREW WAS FLATTENED AND ASYMMETRIC. OUTER DIMENSION OF THE SCREW WAS ALSO FLATTENED. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PROCEDURE UTILIZING AN INTERFERENCE SCREW ON (B)(6), 2011. THE SURGEON MADE SEVERAL ATTEMPTS TO PLACE THE INTERFERENCE SCREW ONTO THE SCREWDRIVER, BUT IT WOULD NOT FIT. THE PROCEDURE WAS COMPLETED USING ANOTHER SCREW THAT WAS ON HAND. NO INJURY TO THE PATIENT OR DELAY TO THE PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSITCP 30 INTERFERENCE SCREW 7X25MM DUOSORB SCREW, FIXATION HWC BIOMET SPORTS MEDICINE N/A 110595

    Patients

    Seq Age Sex Outcome Treatment
    1