BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL TORNADO BURR 4.0MM 5PK

    MDR report key: 11590516 · Received March 30, 2021

    Report

    Report Number
    1221934-2021-01022
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 15, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705022052
    PMA / PMN Number
    K041824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING AN ACL PROCEDURE WHILE USING A 4 MM BARREL TORNADO BUR PLUS, UPON FURTHER INSPECTION AND DISMANTLING THE BURR THEY NOTICED A FILM OF PLASTIC WRAPPED AROUND THE INSIDE SHAFT OF THE BURR. DEVICE WAS REPLACED WITH ANOTHER BURR TO COMPLETE PROCEDURE WITH A SURGICAL DELAY OF 2 MINUTES. STAFF DISCARDED THE BURR AND THEY REMOVED ALL BOXES WITH SAME LOT NUMBER OFF THE SHELF FOR FURTHER INSPECTION. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER A PHOTO WAS PROVIDED BY THE CUSTOMER. UPON REVIEWING THE PHOTO, IT COULD BE OBSERVED THAT THE INNER SHAFT OF THE BURR HAS A PLASTIC SLEEVE WHICH IS PART OF THE BURR ASSEMBLY, THE SLEEVE IS SHOWING SLIPPED AND WRINKLED. AN INVESTIGATION WAS CONDUCTED BY THE MANUFACTURER FOR FURTHER ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE M2003012 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. THE PHOTO OF THE DEVICE WAS EVALUATED BY THE MANUFACTURER WITH THE FOLLOWING RESULTS: THERE IS A 100% INSPECTION PER WORK INSTRUCTION DURING HEAT SHRINKING PROCESS TO DETECT DEFECTIVE PARTS SUCH AS SPLIT SLEEVES, CONTAMINATION OR NOT SLEEVE NOT PROPERLY SHRUNK. IN ADDITION, TEMPERATURE PARAMETER OF THE OVEN USED TO SHRINK SLEEVES WAS REVIEWED FOR REPORTED LOT AND WAS FOUND THAT IT WAS USED WITHIN THE VALIDATED PROCESS RANGE. THE QA SAMPLING METHOD WAS USED TO REVIEW THE SLEEVE IS PROPERLY ATTACHED TO THE TUBE. ALL PERSONNEL THAT PARTICIPATED TO MANUFACTURE THIS REPORTED LOT IS PROPERLY TRAINED ON APPLICABLE WORK INSTRUCTIONS. SINCE THERE ARE CONTROLS SUCH AS 100% INSPECTION IN PLACE TO PREVENT DEFECTIVE PARTS ARE LEAVING THE FACILITY AS WELL AS THERE ARE INDICATION OF PROCESS DEVIATIONS NOR NCRS RELATED TO THIS ISSUE REPORTED. THIS COMPLAINT CAN BE CONFIRMED. CONSIDERING ALL THE PROCESS CONTROLS USED IN THE MANUFACTURING PROCESS, WE CONSIDER THIS TO BE AN ISOLATED CASE. THE PLASTIC SLEEVE IS PART OF THE BURR ASSEMBLY AND IS INTENDED TO PROVIDE STABILITY AND LUBRICATION TO THE BURR. A POSSIBLE ROOT CAUSE FOR THE REPORTED ISSUE CAN BE ATTRIBUTED TO THE HANDLING OF THE DEVICE, HIGHER SPEEDS APPLIED ON THE HANDPIECE CAN INCREASE THE TEMPERATURE OF THE DEVICE'S SHAFT, LACK OF ADEQUATE IRRIGATION AND EXCESSIVE SIDE LOADING CAN CONTRIBUTE TO A SLIPPED SLEEVE, AS PER IFU 110849: ADEQUATE IRRIGATION TO THE TIP OF THE BLADE OR BURR IS REQUIRED TO COOL THE BLADE AND PREVENT ACCUMULATION OF EXCISED MATERIAL IN THE SURGICAL SITE. EXCESSIVE SIDE LOADING MAY RESULT IN BLADE WEAR AND DEGRADATION, AS WELL AS CLOGGING AND/OR SEIZING. 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. H10 CORRECTION NARRATIVE: D9, H3: IT WAS INADVERTENTLY REPORTED ON THE PREVIOUS REPORT THAT THE DEVICE WAS AVAILABLE AND RETURNED FOR EVALUATION. THESE FIELDS HAVE BEEN UPDATED TO REFLECT THAT THE DEVICE THE CORRECT INFORMATION.

    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: D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. ADDITIONAL NARRATIVE: 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 CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE BURR DEVICE HAD A FILM OF PLASTIC WRAPPED AROUND ITS INSIDE SHAFT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484806 BARREL TORNADO BURR 4.0MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE HRX DEPUY MITEK LLC US 283489 M2003012 10886705022052

    Patients

    Seq Age Sex Outcome Treatment
    1