BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOSPHERE FORCEPS

    MDR report key: 2821057 · Received November 6, 2012

    Report

    Report Number
    0001825034-2012-02362
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF DEVICE FOUND EVIDENCE THAT FAILURE MODE WAS DUE TO OVERLOAD. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION.THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING."(B)(4)

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. LISTED UNDER CARE AND HANDLING IS STATES: "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING." THIS REPORT IS NUMBER 1 OF 1 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2012-02362).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT REPORTED PAIN AND A SCOPE PROCEDURE WAS PERFORMED (B)(6) 2012 TO REMOVE A PORTION OF THE INSERTER THAT HAD FRACTURED OFF DURING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLENOSPHERE FORCEPS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HTD BIOMET ORTHOPEDICS N/A 753430

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R