BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA

    MDR report key: 11089221 · Received December 29, 2020

    Report

    Report Number
    1221934-2020-04125
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 15, 2020
    Report Date
    December 15, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705007042
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE ARTICLES RUST. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION REVEALS THE DEVICE IS DULL, WORN, LASER MARKINGS ARE SLIGHTLY FADED AND CORRODED. ALSO, THE DEVICE HAD MARKS OF DISCOLORATION. THE COMPLAINT CAN BE CONFIRMED. THE POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO FAIR WEAR AND TEAR OF THE DEVICE; ALSO, THE DISCOLORATION MARKS POSSIBLY FROM THE REPEATED USE AND STERILIZATION CYCLES. ACCORDING TO IFU-1006674, THE PRECAUTIONS FOR THIS TYPE OF DEVICE CONSIST TO INSPECT THE CONDITION OF THE DEVICE PRIOR TO USE. THIS DEVICE CAN DAMAGE AND WORN; THEREFORE, WHEN THIS OCCURS IT NEED TO REPLACE. IT IS NECESSARY TO FOLLOW THE INSTRUCTIONS AND WARNINGS OF ANY CLEANING AND DISINFECTION AGENTS AND EQUIPMENT USED; ALSO, THE RECOMMENDATION OF THE PROPER CONDITION DURING THE STERILIZATION AND MAINTENANCE TO AVOID ANY DAMAGE. AS A POTENTIAL CAUSE CANNOT BE ASSOCIATED TO MANUFACTURING, THEREFORE A MANUFACTURING RECORD EVALUATION IS NOT REQUIRED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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 · 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. D4: THE LOT NUMBER WAS REPORTED A UNKNOWN ON THE INITIAL REPORT; AND HAS BEEN UPDATED ACCORDINGLY. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4) INCOMPLETE THE LOT NUMBER WAS UNKNOWN. 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 AFFILIATE IN (B)(6) THAT DURING INSPECTION ON (B)(6) 2020, IT WAS OBSERVED THAT THE GRAFT PREP SYSTEM SLIDER UNIT DEVICE WAS CORRODED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554560 GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA GRAFT PREPARATION STATION LXH DEPUY MITEK LLC US 219962 1901001 10886705007042

    Patients

    Seq Age Sex Outcome Treatment
    1