BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 POSITIONING GUIDE ROD

    MDR report key: 20673626 · Received November 13, 2024

    Report

    Report Number
    0001825034-2024-02676
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 18, 2024
    Report Date
    February 19, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110010717 G7 DEPTH GAUGE 072793. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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 AND/OR CORRECTED INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE TIP OF THE DEPTH GAUGE HAD FRACTURED. NO PICTURES OF THE GUIDE ROD WERE PROVIDED. NO FURTHER EVALUATION COULD BE MADE WITH THE PROVIDED PICTURES. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED BASED ON THE PHOTO OF THE FRACTURED DEPTH GAUGE. FRACTURED GUIDE ROD COULD NOT BE CONFIRMED. 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 DEPTH GAUGE BROKE DURING SURGERY WHILE MEASURING FOR A SCREW AND THAT THE POSITIONING GUIDE ROD BROKE AS WELL WHEN TIGHTENING DOWN ONTO THE VERSION GUIDE. NO PIECES FELL INTO THE PATIENT. A BACKUP TRAY WAS OPENED AND UTILIZED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070172 G7 POSITIONING GUIDE ROD HIPS, INSTRUMENTS LXH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female