BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM BONE DOWEL COLLET

    MDR report key: 3121736 · Received May 21, 2013

    Report

    Report Number
    0001825034-2013-01590
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. EVALUATION OF RETURNED DEVICE FOUND EVIDENCE THAT INSTRUMENT FRACTURED DUE TO EXCESSIVE FORCE/EXTENSIVE USE.

    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 STATES, "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 SPORTS MEDICINE RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT." DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE INSTRUMENT FRACTURED AND THE FRACTURED PIECES FELL INTO THE SURGICAL SITE. THE SURGEON WAS ABLE TO REMOVE ALL THE PIECES AND COMPLETED THE PROCEDURE WITH ANOTHER SET OF INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223932 8MM BONE DOWEL COLLET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET SPORTS MEDICINE N/A 570640

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R