BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATOR #301

    MDR report key: 6649854 · Received June 19, 2017

    Report

    Report Number
    0001032347-2017-00501
    Event Type
    Injury
    Date Received
    June 19, 2017
    Report Date
    June 16, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00391.

    Additional Manufacturer Narrative · 1

    TWO ELEVATORS #301 WERE RETURNED WITHOUT PACKAGING. THE ELEVATORS WERE VISUALLY EVALUATED AND THE TIP WAS FOUND TO HAVE BEEN BROKEN OFF ON BOTH INSTRUMENTS. THERE ARE SCRATCHES AND NORMAL SIGNS OF WEAR INDICATING THE USE OF THE INSTRUMENTS; NO DISCOLORATION WAS OBSERVED. THE COMPLAINT WAS CONFIRMED AS THE INSTRUMENT TIP WAS BROKEN OFF ON BOTH INSTRUMENTS. THE MOST LIKELY CAUSE OF THE FRACTURE WAS DETERMINED TO BE EXCESSIVE FORCE BY THE USER. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT STATES IN THE SECTION TITLED WARNINGS AND PRECAUTIONS: ¿THE TIP OF THE INSTRUMENT IS EXTREMELY THIN AND DELICATE, CARE SHOULD BE TAKEN TO AVOID APPLYING SIGNIFICANT PRESSURE TO THE TIP.¿ THE NON-CONFORMANCE DATABASE WAS REVIEWED AND THERE WAS NOT A NON-CONFORMANCE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT; REPORT ONE OF TWO IS REPORTED ON MFR #0001032347-2017-00391-2.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO ELEVATORS BROKE DURING A PROCEDURE. THE SURGEON WAS ABLE TO RETRIEVE ALL BROKEN PIECES FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING ANOTHER ELEVATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430052 ELEVATOR #301 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A 082412H12

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention