BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAGE 2.0/2.4 45MM LONG

    MDR report key: 18922980 · Received March 18, 2024

    Report

    Report Number
    0001032347-2024-00095
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    January 14, 2024
    Report Date
    May 10, 2024
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EIL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). 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 FOLLOWING SECTIONS WERE CORRECTED H6 - HEALTH IMPACT. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEPTH GAUGE. THE GAUGE SHOWS SIGNS OF MULTIPLE USES INCLUDING HEAVY MARKING AND SCRATCHING ON THE GAUGE SURFACE. FURTHER INSPECTION WAS CONDUCTED ON THE GAUGE TIP. THE TIP FOR THE DEPTH GAUGE HAS FRACTURED. THE FRACTURED VERSION ON THE DEPTH GAUGE WAS NOT RETURNED. A DETERMINATION CANNOT BE MADE AS TO WHAT CAUSED THE DEVICE TO FRACTURE. DHR REVIEW WAS NOT PERFORMED AS PRODUCT HAS APPROXIMATE FIELD AGE OF 15 YEARS, WITH AN UNKNOWN NUMBER OF USES. THE DEVICE SHOWS SIGNS OF REPEATED USE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED, BASED ON EVALUATION OF THE RETURNED PRODUCT. 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 · 0

    IT IS REPORTED THAT THE INSTRUMENT WAS DISCOVERED FRACTURED DURING RESTOCKING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    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
    141628 DEPTH GAGE 2.0/2.4 45MM LONG GAUGE, DEPTH, INSTRUMENT, DENTAL EIL BIOMET MICROFIXATION N/A 538334
    955993 DEPTH GAGE 2.0/2.4 45MM LONG GAUGE, DEPTH, INSTRUMENT, DENTAL EIL BIOMET MICROFIXATION N/A 538334

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown