BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST

    MDR report key: 13417753 · Received February 1, 2022

    Report

    Report Number
    1221934-2022-00364
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEA
    UDI-DI
    10886705003617
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: UDI: (B)(4). INCOMPLETE. 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.

    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. H4: THE DEVICE MANUFACTURE DATE WAS REPORTED AS UNKNOWN ON THE INITIAL REPORT; AND HAS BEEN UPDATED ACCORDINGLY. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION, HOWEVER THE CUSTOMER PROVIDED A PHOTO, UPON VISUAL INSPECTION OF THE PHOTO, IT COULD BE OBSERVED THAT THE CANNULA IS SHOWING THE SILICONE SEAL DETACHED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 2103222 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 INSPECTION OF THE PHOTO, THIS COMPLAINT CAN BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR REPORTED FAILURE CAN BE ATTRIBUTED TO PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE; EXCESSIVE FORCE BEING APPLIED TO PASS INSTRUMENTS THROUGH THE CANNULA WHICH WOULD CAUSE A DETACHMENT OF THE SILICONE SEAL, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE RUBBER SEAL WAS DEFECTIVE ON THE CLEAR CANNULA-THREADED 8.5MMX75MM DEVICE THAT IT CAME LOOSE AND FLOATED AROUND IN THE SITUS. IT WAS REPORTED THAT THROUGH EXTENSIVE SEARCHING IT WAS RECOVERED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501315 CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST ARTHROSCOPIC DRAINAGE CANNULA GEA DEPUY MITEK LLC US 214120 2103222 10886705003617

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown