BEUDAMED
    FDA Adverse Event Injury Summary report: N

    17MM FLARED BONE MULCH SCREW

    MDR report key: 3892510 · Received June 24, 2014

    Report

    Report Number
    0001825034-2014-05766
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    August 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PK941941
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 2 STATES, "BENDING OR FRACTURE OF THE IMPLANT."

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT FOUND FRACTURE ARTIFACT EVIDENCE TO SUGGEST THE FRACTURE OCCURRED DUE TO POSSIBLE DUCTILE BENDING OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE SCREW BENT WHILE TIGHTENING THE GRAFT AND A SECOND SCREW WAS ATTEMPTED. THE SHAFT OF THE SECOND SCREW FRACTURED AFTER TIGHTENING. THE SCREW HEAD WAS REMOVED AND A DIFFERENT SCREW WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367783 17MM FLARED BONE MULCH SCREW PROSTHESIS, HIP HWC BIOMET ORTHOPEDICS N/A 214580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R