BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX TRIMANO FORTIS

    MDR report key: 11600939 · Received April 1, 2021

    Report

    Report Number
    8010652-2021-00016
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    February 11, 2021
    Report Date
    November 22, 2021
    Manufacturer
    HOLGER ULLRICH
    Product Code
    BWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE REQUESTED THE AFFECTED DEVICE FOR FURTHER INVESTIGATION, BUT IT WAS SCRAPPED ACCIDENTALLY. A REVIEW OF OUR COMPLAINTS DATABASE AND COMMUNICATION WITH THE DISTRIBUTOR OF THIS DEVICE REVEALED THAT THE SAME DEVICE (SERIAL NUMBER (B)(6)) WAS CLAIMED IN (B)(6) 2020. THE DEVICE WAS RETURNED TO THE MANUFACTURING SITE AND INVESTIGATED. THIS INVESTIGATION REVEALED, THAT THERE WERE SEVERAL COLLISION MARKS ON THE DEVICE. THEREFORE WE ASSUMED, THAT THE USER HAS DAMAGED THE DEVICE. A REPAIR WAS OFFERED, BUT THE CUSTOMER DID NOT AGREE AND THE DEVICE WAS RETURNED TO THE CUSTOMER WITHOUT REPAIR. THE CUSTOMER WAS INFORMED THAT THE DEVICE WAS NOT REPAIRED AND NOT SAVE TO BE USED. THE SAME DEVICE SEEMED TO BE RETURNED TO USE AND THE CLINIC RECOGNIZED THAT IT WAS NOT SAVE TO BE USED. WE ASSUME THAT THE DEVICE WAS INITIALLY DAMAGED DUE TO USE ERRORS LIKE COLLISIONS OR ROUGH HANDLING. IN THE INSTRUCTIONS FOR USE (IFU) THE USER IS TOLD ABOUT THE RISKS RELATED TO COLLISIONS AND ADVISED TO AVOID THEM: "RISK OF INJURY! WHEN ADJUSTING AND MOVING THE OR TABLE, THE TRANSPORTER, THE TABLE TOP OR THE ACCESSORIES, AS WELL AS WHEN CARRYING OUT A TABLE TOP TRANSFER, COLLISIONS MAY OCCUR BETWEEN THE PATIENT AND INDIVIDUAL PRODUCTS OR PARTS THAT ARE POINTING DOWNWARDS. DURING ADJUSTMENTS, OBSERVE THE OR TABLE, THE TRANSPORTER, THE TABLE TOP AND ACCESSORIES CONSTANTLY AND AVOID COLLISIONS. ENSURE THAT TUBES, CABLES AND DRAPES ARE NOT TRAPPED." BESIDES THE USER IS TOLD IN THE IFU NOT TO USE A DEFECTIVE PRODUCT AND WARNED CONCERNING THE RISKS RELATED TO USING IT: "WARNING! RISK OF INJURY! FAULTY OR DEFECTIVE PRODUCTS MAY RESULT IN INJURIES. BEFORE USE, CHECK THE PROPER WORKING ORDER AND FULLY FUNCTIONAL STATE OF THE PRODUCT. STOP USING FAULTY OR DEFECTIVE PRODUCTS." GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    NO INJURY OR PATIENT INVOLVEMENT WAS REPORTED TO US. MANUFACTURER REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS COMPLETE THE REPORT WILL BE UPDATED AND A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(6).

    Description of Event or Problem · 1

    THE CLINIC HAS FILED A USER REPORT. IN THIS REPORT IT WAS STATED THAT THE USER THINKS, THAT THERE MIGHT BE POTENTIALLY SERIOUS PATIENT CONSEQUENCES (="CONSEQUENCES PATIENTS POTENTIELLEMENT GRAVES"). FURTHER INFORMATION WAS REQUESTED, BUT NOT YET PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500413 ARTHREX TRIMANO FORTIS TABLE AND ATTACHMENTS, OPERATING-ROOM BWN HOLGER ULLRICH 100230R0 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other N/A.| N/A.