BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHSCO,4/140_30_QIK/STRKR HUB

    MDR report key: 11038395 · Received December 18, 2020

    Report

    Report Number
    1221934-2020-03939
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Date of Event
    December 1, 2020
    Report Date
    December 3, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    HRX
    UDI-DI
    10886705026234
    PMA / PMN Number
    K971996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED AT THE SERVICE CENTER. THE REPORTED COMPLAINT THAT THE SCOPE HAD FOGGED AND THEY ARE NOT ABLE TO SEE CLEARLY THROUGH IT WAS CONFIRMED. THE FOLLOWING DEFECTS WERE FOUND DURING EVALUATION : TUBE BENT AND DENTED. DISTAL TIP DAMAGED. OPTICS DAMAGED. IMAGE DARK. THE SCOPE WAS CLEANED INTERNALLY, THE OBJECTIVE AND 3 ROD LENSES WERE REPLACED AND THE DEVICE WAS TESTED AND FOUND TO BE WORKING ACCORDING TO SPECIFICATIONS. THE IDENTIFIED FAILURES ARE CLEAR SIGNS OF PHYSICAL MISHANDLING OF THE DEVICE BY THE CUSTOMER. THE DAMAGED COMPONENTS WOULD HAVE CAUSED THE POOR IMAGE AS REPORTED BY THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (SERIAL NUMBER : (B)(6)), 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.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE ARTHSCO,4/140 30 QIK/STRKR HUB DEVICE HAD FOGGED AND THEY WERE NOT ABLE TO SEE CLEARLY THROUGH IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO SURGICAL DELAY OR PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506691 ARTHSCO,4/140_30_QIK/STRKR HUB RIGID ENDOSCOPE HRX MEDOS INTERNATIONAL SàRL 242043 10886705026234

    Patients

    Seq Age Sex Outcome Treatment
    1