BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 DEPTH GAUGE

    MDR report key: 19271415 · Received May 8, 2024

    Report

    Report Number
    0001825034-2024-01175
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 17, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304569003
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: D4, D9, G3, H2, H3, H4, H6 ONE G7 DEPTH GAUGE ITEM# 110010717 LOT# 060061 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE DEVICE HAS FRACTURED AT THE FIRST NOTCH OF THE MEASUREMENT TIP. THERE IS VISIBLE SCUFFING AND DAMAGE TO THE REMAINING HANDLE. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED VIA RETURNED PRODUCT. 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.

    Additional Manufacturer Narrative · 0

    (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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TIP OF THE DEPTH GAUGE BROKE DURING SURGERY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752691 G7 DEPTH GAUGE HIPS, INSTRUMENTS JDI ZIMMER BIOMET, INC. N/A 060061 00880304569003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown