BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SERIES HUDSON HTQ RMER ATTACH

    MDR report key: 21053290 · Received January 2, 2025

    Report

    Report Number
    0008031000-2025-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 5, 2024
    Report Date
    June 5, 2025
    Manufacturer
    ZIMMER SURGICAL SA
    Product Code
    GEY
    UDI-DI
    00889024521230
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) G2 ¿ FOREIGN ¿ GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G1, G3, G6, H1, H2, H3, H4, H6, H11. CORRECTED INFORMATION: D4 UDI NUMBER. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE REPORTED EVENT COULD NOT BE DUPLICATED AS THE DEVICE PASSED THE DRILL LOCKING TEST. HOWEVER, THE LOCKING MECHANISM WAS DAMAGED. THE UNIT WAS SCRAPPED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT CANNOT 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

    THE LOSS OF ATTACHMENT OF THE DRILL ADAPTER WAS REPORTED. NO CONSEQUENCES OR IMPACT ON THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    1536414 X-SERIES HUDSON HTQ RMER ATTACH SURGICAL POWER TOOL GEY ZIMMER SURGICAL SA 5014946 00889024521230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown