BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHSCO,4/140_30_QIK/STRKR HUB

    MDR report key: 8828207 · Received July 25, 2019

    Report

    Report Number
    1221934-2019-57801
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    June 23, 2019
    Report Date
    July 1, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    HRX
    UDI-DI
    10886705026234
    PMA / PMN Number
    K971996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE WAS SENT TO THE SUPPLIER AND EVALUATED. THE CUSTOMER REPORTED AN ISSUE OF HAVING DIFFICULTY TO FOCUS CORRECTLY, PER EVALUATION REPORT IT CAN BE VERIFIED, THEREFORE THIS COMPLAINT CAN BE CONFIRMED. IT WAS FOUND DURING EVALUATION THAT DISTAL TIP & OPTICS WERE DAMAGED AND TUBE WAS DENTED. REPLACED OBJECTIVE WINDOW, ROD LENS AND POLISHED DISTAL FIBERS. USER MISHANDLING IS A POSSIBLE ROOT CAUSE FOR THE REPORTED ISSUE. OTHER THAN THAT WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE SERIAL NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE FACILITY STATED THAT THE ARTHROSCOPE 4/140 30 QIK/STRIKER HUB COULD NOT FOCUS CORRECTLY. THEY WERE ABLE TO COMPLETE THE CASE USING ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620833 ARTHSCO,4/140_30_QIK/STRKR HUB RIGID ENDOSCOPE HRX MEDOS INTERNATIONAL SàRL 10886705026234

    Patients

    Seq Age Sex Outcome Treatment
    1