BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOSPHERE FORCEPS

    MDR report key: 3114391 · Received May 15, 2013

    Report

    Report Number
    0001825034-2013-01518
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HYA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PRECAUTIONS IT LISTS, "INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED. SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS THAT HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE. BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT REVERSE SHOULDER PROCEDURE ON (B)(6) 2013. POST OPERATIVE RADIOGRAPHS SHOWED A PIECE OF THE INSTRUMENT HAD FRACTURED AND REMAINED IN THE PATIENT. SUBSEQUENTLY, PATIENT UNDERWENT PROCEDURE ON (B)(6) 2013 TO REMOVE THE FRACTURED PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215741 GLENOSPHERE FORCEPS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HYA BIOMET ORTHOPEDICS N/A 248070

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R