BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 8238883 · Received January 11, 2019

    Report

    Report Number
    3009185973-2019-00011
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Report Date
    April 12, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    NAY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE GUIDEWIRE NAVIGATION REFERENCE WAS BROKEN. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A VISUAL INSPECTION CONFIRMED THAT PART RECEIVED WAS DAMAGED. IT IS ASSUMED THAT THE GUIDEWIRE NAVIGATION REFERENCE BROKE WHEN THE USER HIT IT TO PUSH THE GUIDEWIRE INTO THE BONE (NORMAL PROCESS). THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA SPINE, CLASSIFIED OLO AND CLEARED UNDER K151511.

    Description of Event or Problem · 0

    THE FIELD SERVICE ENGINEER WAS INFORMED ON WED. DEC. 11TH THAT THE GUIDEWIRE HANDLE (B)(6) WAS BROKEN.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER WAS INFORMED ON WED. DEC. 11TH THAT THE GUIDEWIRE HANDLE MT-02-191 S16009 WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35072 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE NAY MEDTECH SA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1