BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL REPAIR 27DEG

    MDR report key: 11855793 · Received May 20, 2021

    Report

    Report Number
    1221934-2021-01595
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 8, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705010042
    PMA / PMN Number
    K150209
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. D4, H4: THE EXPIRATION AND DEVICE MANUFACTURE DATES WERE REPORTED AS UNKNOWN ON THE INITIAL REPORT; AND HAVE BEEN UPDATED ACCORDINGLY. THEREFORE, UDI: (B)(4). INVESTIGATION SUMMARY : ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING THE SURGERY OF MENISCUS REPAIR, AFTER 1ST FIRING WITH 228141, COULD NOT FIRE AGAIN, REMOVED THE DEVICE, NOTED THE 2ND PLATE WAS OUR OF THE NEEDLE. THE SAME ISSUE OCCURRED ON 228142. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION, HOWEVER A PHOTO WAS PROVIDED. UPON VISUAL INSPECTION OF THE PHOTO, IT WAS OBSERVED THE INTERIOR OF THE JOINT, HOWEVER, THE IMAGE IS BLURRY AND IS HARD TO IDENTIFY THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L973616 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF DEPUY SYNTHES MITEK QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ACCORDING WITH THE VISUAL INSPECTION OF THE PHOTO, THIS COMPLAINT CANNOT BE CONFIRMED. THE PHOTO PROVIDED DOES NOT CONTAIN ENOUGH EVIDENCE TO DETERMINE WHY THE CUSTOMER EXPERIENCED THE FAILURE, HANDS ON ANALYSIS SHOULD PROVIDE THE EVIDENCE NECESSARY TO PROVIDE A ROOT CAUSE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO MONITOR ADDITIONAL COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE. 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 HEALTHCARE PROFESSIONAL IN (B)(6) THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE OMNISPAN MENISCAL REPAIR SYSTEM/12 DEGREE DEVICE DID NOT FIRE AGAIN AFTER THE FIRST FIRING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755140 OMNISPAN MENISCAL REPAIR 27DEG SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 228142 L973616 10886705010042

    Patients

    Seq Age Sex Outcome Treatment
    1