BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLE THREAD 8X25MM FULL THRD

    MDR report key: 3872782 · Received June 13, 2014

    Report

    Report Number
    0001825034-2014-05528
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 24, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PK041274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. EVALUATION OF DEVICE FOUND EVIDENCE THAT FAILURE MODE WAS DUE TO EXCESSIVE TORQUE.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, "BENDING, FRACTURE, LOOSENING, RUBBING, AND MIGRATION OF THE IMPLANT MAY OCCUR AS A RESULT OF EXCESSIVE ACTIVITY, TRAUMA, OR LOAD BEARING."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE GT SCREW FRACTURED WHILE INSERTING THE COMPONENT. THE FRACTURED FRAGMENT COULD NOT BE REMOVED; THEREFORE, PATIENT RETAINED A FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349735 GENTLE THREAD 8X25MM FULL THRD SCREW, FIXATION HWC BIOMET ORTHOPEDICS N/A 355160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R