BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM REVERSE CURETTE

    MDR report key: 4211818 · Received October 29, 2014

    Report

    Report Number
    0001825034-2014-08440
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JXE
    PMA / PMN Number
    PK031280
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: " INTRAOPERATIVE FRACTURE OR BREAKAGE OF INSTRUMENTS HAS BEEN REPORTED. SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS, WHICH 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 THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF COMPETITOR¿S COMPONENTS AND THE 5MM REVERSE CURETTE FRACTURED WHILE EXTRACTING BONE CEMENT. THE TIP WAS RETAINED IN THE PATIENT'S BONE CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692420 5MM REVERSE CURETTE NERVE CONDUCTION VELOCITY MEASUREMENT JXE BIOMET ORTHOPEDICS N/A 670910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention