BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE

    MDR report key: 19918259 · Received August 6, 2024

    Report

    Report Number
    0009613350-2024-00327
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) G2: REPORT SOURCE CANADA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 WAS REPORTED DURING THE PROCEDURE THAT WHEN TRYING TO MEASURE WHAT SCREW LENGTH IS REQUIRED, THE DEPTH GAUGE BROKE AT THE JUNCTION MAKING IT UNUSABLE. THE SURGERY WAS COMPLETED WITH ANOTHER DEPTH GAUGE. NO PATIENT HARM OR INJURY HAS BEEN REPORTED AS A RESULT OF THIS EVENT, HOWEVER THIS MALFUNCTION HAS LED TO ADVERSE EVENTS IN THE PAST. 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702367 DEPTH GAUGE HIP, INSTRUMENTS HJT ZIMMER GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown