BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATOR #77R

    MDR report key: 6017087 · Received October 11, 2016

    Report

    Report Number
    0001032347-2016-00570
    Event Type
    Injury
    Date Received
    October 11, 2016
    Report Date
    June 20, 2016
    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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE PRODUCT WAS RETURNED FOR EVALUATION. IN THE EVALUATION THE IDENTITY HAS BEEN CONFIRMED. A VISUAL INSPECTION REVEALED MINOR SCRATCHES ALONG THE LENGTH OF THE INSTRUMENTS AND, ON EACH ELEVATOR, A FRACTURED TIP; THEREFORE THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT WAS DETERMINED TO BE EXCESSIVE FORCE EXPERIENCED AT THE TIP. THE NON-CONFORMANCE DATABASE WAS REVIEWED AND NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE REASON FOR THIS LATE REPORT IS HUMAN ERROR. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. REPORT 1 OF 2 IS REPORTED ON MFR #0001032347-2016-00569.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT TWO OF TWO, REFERENCE 000001032347-2016-00569-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE ELEVATORS BROKE OFF DURING USE. IT WAS REPORTED THAT A DELAY IN SURGERY DID NOT RESULT FROM THIS EVENT. IT IS REPORTED THAT ALL PARTS WERE RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667976 ELEVATOR #77R ELEVATOR EMJ BIOMET MICROFIXATION N/A 012014A14

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention