BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 18545066 · Received January 19, 2024

    Report

    Report Number
    3009185973-2024-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    January 8, 2024
    Report Date
    January 8, 2025
    Manufacturer
    MEDTECH SAS
    Product Code
    OLO
    PMA / PMN Number
    K210121
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2- (B)(6). H3- 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 9617840.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS REPORTED THAT DURING THE CASE THE BLACK SENSOR CABLE BECAME LOOSE CAUSING A LOSS IN CONNECTION AND WAS LATER TIGHTENED. THE CAUSE OF THE LOOSENING OF THE CABLE WAS NOT REPORTED. PHYSICAL AND TECHNICAL EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER (FSE) AND THE FSE FOUND NO MALFUNCTION. THE SERIAL NUMBER WAS REVIEWED FOR ANY DEVIATIONS AND/OR ANOMALIES IN THE SERVICING/MAINTENANCE PROCESS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED EVENT. NO DEVIATIONS OR ANOMALIES WERE DISCOVERED; THEREFORE, IT IS NOT EXPECTED THAT THE SERVICING/MAINTENANCE PROCESS CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED ISSUE NOT BEING CONFIRMED TO BE PRIOR TO FIRST USE SUGGESTS IT IS UNLIKELY TO BE THE RESULT OF MANUFACTURING. AS SUCH, A MANUFACTURING DHR REVIEW WAS NOT PERFORMED. THE ROOT CAUSE CANNOT BE DETERMINED AS THERE WAS NO INFORMATION AVAILABLE TO THE CIRCUMSTANCES LEADING TO THE LOOSENED CABLE. IF ANY FURTHER INFORMATION IS RECEIVED 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 THAT DURING THE CASE, THE BLACK CABLE WHICH CONNECTS THE TORQUE SENSOR LOST ITS CONNECTION DURING THE TIBIAL CUT. WHEN THE ROBOT WAS PULLED BACK AND LOOKED AT, IT WAS SEEN THAT THE CONNECTION OF THE BLACK CABLE WAS DISCONNECTED. THE CONNECTION POINT OF THE CABLE WAS TIGHTENED. AFTER TIGHTENING THE SCREW SIDE OF THE CABLE, THE FAULT DISAPPEARED. ALL CUTS WERE FINISHED WHEN THE MALFUNCTION OCCURRED. THERE WAS NO NEGATIVE EFFECT ON THE PATIENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 9617840.

    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
    1123140 ROSA RECON PLATFORM 220V ROBOTIC SURGICAL ARM SYSTEM OLO MEDTECH SAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown