BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE FORCEPS

    MDR report key: 5846082 · Received August 4, 2016

    Report

    Report Number
    0001825034-2016-02869
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Report Date
    August 16, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HYA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. UNDER CARE AND HANDLING INSTRUMENTS, IT STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR EXACTING PERFORMANCE." DEVICE REQUESTED, NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. REVIEW OF THE DEVICE CONFIRMED THE REPORTED CONDITION AS THE TIP OF ONE OF THE FORCEPS ARMS WAS CHIPPED. PRODUCT MOST LIKELY FAILED DUE TO BENDING OVERLOAD WHILE IMPLANTING THE GLENOSPHERE; HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE FOLDED TIP OF THE FORCEPS WAS FRACTURED UPON RETURN FROM THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT OR DELAY IN A PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499340 GLENOSPHERE FORCEPS FORCEPS, WIRE HOLDING HYA BIOMET ORTHOPEDICS N/A 248130

    Patients

    Seq Age Sex Outcome Treatment
    1