BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSBRAID 10PK BLUE/WHITE

    MDR report key: 5675952 · Received May 24, 2016

    Report

    Report Number
    0001825034-2016-01659
    Event Type
    Malfunction
    Date Received
    May 24, 2016
    Date of Event
    April 25, 2016
    Report Date
    April 25, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTD
    PMA / PMN Number
    PK040472
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. PRODUCT DEVICE CODE - GAT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS, IT STATES, "INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED FOR GENERAL INSTRUMENTS," AND, "BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT PRIOR TO USE." UNDER WARNINGS, NUMBER 8 STATES, "THE SURGEON IS TO BE FAMILIAR WITH THE EQUIPMENT, INSTRUMENTS AND SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY." DEVICE DISCARDED.

    Description of Event or Problem · 1

    DURING REPAIR OF AN ANTERIOR CRUCIATE LIGAMENT, THE SUTURE SEPARATED FROM THE NEEDLE AND COULD NOT BE USED. ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331099 EXPRESSBRAID 10PK BLUE/WHITE SUTURE, NONABSORBABLE HTD BIOMET ORTHOPEDICS N/A 455690

    Patients

    Seq Age Sex Outcome Treatment
    1