BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRS SCREW 12MM L X 2.5MM D

    MDR report key: 3981741 · Received August 5, 2014

    Report

    Report Number
    0001825034-2014-06838
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    January 26, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PK062352
    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. PRODUCT LIKELY FAILED DUE TO MISUSE AND BY PRODUCT BEING PUT THROUGH OBSERVED HEAD FAILURES OF, HEAD CRACKING DURING SCREWING AND HEAD DEFORMATION DURING EXTRACTING. THE FAILURE OF THE SCREW IS CERTAINLY DUE TO A SUDDEN STRESS APPLIED DURING THE INSERTION OF THE SCREW, AND/OR NOT BEING INSPECTED FOR WEAR AND DISFIGUREMENT AND PRIOR TO USE.

    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. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE HEAD OF THE SCREW FRACTURED. THE SCREW WAS REMOVED AND ANOTHER SCREW WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457296 FRS SCREW 12MM L X 2.5MM D SCREW, FIXATION HWC BIOMET ORTHOPEDICS N/A 5210858

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention