BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ PASS 30 DEGREE LEFT

    MDR report key: 6125310 · Received November 23, 2016

    Report

    Report Number
    0001825034-2016-04871
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 28, 2016
    Report Date
    June 1, 2017
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HWQ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT OCCURRED DURING A CADAVER LAB ON CAMPUS; HOWEVER THE DEVICE LOCATION IS NOW UNKNOWN. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS: 6. CORRECT HANDLING OF INSTRUMENTS IS EXTREMELY IMPORTANT. MOST INSTRUMENTS ARE NOT INTENDED TO BE MODIFIED, NOTCHED, BENT, ETC. AS NOTCHES, SCRATCHES OR OTHER DAMAGE AND/OR WEAR IN THE INSTRUMENT OCCURRING DURING SURGERY MAY CONTRIBUTE TO BREAKAGE OR AFFECT THE PERFORMANCE OF THE INSTRUMENT. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04868 / 04871).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    PASSER DID NOT ADVANCE DURING A CADAVER LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776819 EZ PASS 30 DEGREE LEFT PASSER HWQ BIOMET SPORTS MEDICINE N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1