BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SERIES ZIMMER/HUDSON HTQ RMER ATTACH

    MDR report key: 21053302 · Received January 2, 2025

    Report

    Report Number
    0008031000-2025-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 5, 2024
    Report Date
    June 6, 2025
    Manufacturer
    ZIMMER SURGICAL SA
    Product Code
    GEY
    UDI-DI
    00889024521261
    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, D4, G1, G3, G6, H1, H2, H3, H4, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D4 PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER. REVIEW OF THE MOST RECENT CHECKLIST DETERMINED THE DEVICE PASSED THE HANDPIECE AND DRILL LOCKING CHECK; HOWEVER, THE DRILL LOCKING SYSTEM WAS DAMAGED. THE DEVICE WAS SCRAPPED. REVIEW OF THE PREVIOUS CHECKLIST IDENTIFIED NO RELATED REPAIRS/FINDINGS TO THE REPORTED EVENT. THE DEVICE WAS TESTED AND FOUND TO BE FUNCTIONING TO SPECIFICATIONS PRIOR TO RELEASE TO THE CUSTOMER. 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

    IT WAS REPORTED THAT THE DRILL ADAPTER WAS KNOCKED OUT. NO CONSEQUENCES OR IMPACT TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION 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
    1537396 X-SERIES ZIMMER/HUDSON HTQ RMER ATTACH SURGICAL POWER TOOL GEY ZIMMER SURGICAL SA 5015192 00889024521261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown