BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAGE 2.0/2.4 45MM LONG

    MDR report key: 13522708 · Received February 14, 2022

    Report

    Report Number
    0001032347-2022-00048
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Report Date
    June 7, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EIL
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). DEVICE PRODUCT CODE: EIL. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS LOST POST RECEIPT. AS A RESULT FUNCTIONAL AND VISUAL TESTING CANNOT BE COMPLETED ON THESE ITEMS. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED FOR THE DEPTH GAUGE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE IS BROKEN. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAYS INVOLVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699214 DEPTH GAGE 2.0/2.4 45MM LONG GAUGE, DEPTH, INSTRUMENT, DENTAL EIL BIOMET MICROFIXATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown