BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON SLOTTED FISHMOUTH GDE

    MDR report key: 11399756 · Received March 2, 2021

    Report

    Report Number
    1221934-2021-00710
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Report Date
    February 17, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    LXH
    UDI-DI
    10886705024131
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING THE PROCEDURE THE HANDLE SEPARATED FROM THE SHAFT OF THE GRYPHON SLOTTED GUIDE (210826) WHILE DRILLING. THE PRODUCT WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED PROVIDED BY CUSTOMER. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THAT THE HANDLE AND THE SHAFT OF THE DEVICE HAD BEEN SEPARATED. A VISUAL INSPECTION REVEALED THAT THE DEVICE HAD BEEN HEAVILY USED AS STRIATIONS ON THE METAL SURFACE OF THE HANDLE DISTAL FROM THE SHAFT CONNECTION POINT. THE VISUAL INSPECTION ALSO REVEALED SMALL INDENTATIONS ON THE SHAFT SLOT NEAREST TO THE CONNECTION POINT TO THE HANDLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 1311002 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. BASED ON THE VISUAL INSPECTION RESULT, THIS COMPLAINT CAN BE CONFIRMED. NO INFORMATION WAS PROVIDED ON HOW OR WHEN THE FAILURE HAS OCCURRED, THEREFORE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. SINCE THIS DEVICE IS REUSABLE, THE BROKEN WELD FAILURE COULD BE DUE TO THE DEVICE BEING DROPPED/ MISHANDLED ON HARD SURFACE CAUSING THE WELD TO FAIL. AS PER IFU, 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. FOR THE INSTRUMENT LIFE, 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. A FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT THAT WERE RELEASED TO DISTRIBUTION. AS PART OF MITEK¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, IN DEPUY SYNTHES MITEK, ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    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 · 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. H11 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE HANDLE SEPARATED FROM THE SHAFT OF THE SLOTTED GUIDE WHILE DRILLING. THE COMPLAINT DEVICE WAS NOT RETURNED, DESPITE THE MULTIPLES ATTEMPTS FOR PRODUCT RETURN, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [1311002] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 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). 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 SALES REP THAT DURING A SHOULDER ARTHROSCOPY WITH A LABRUM REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDLE ON THE GRYPHON SLOTTED FISHMOUTH GDE DEVICE SEPARATED FROM ITS SHAFT WHILE DRILLING. THERE WAS NO DELAY IN 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
    298478 GRYPHON SLOTTED FISHMOUTH GDE BONENAIL GUIDEWIRE LXH MEDOS INTERNATIONAL SARL 210826 10886705024131

    Patients

    Seq Age Sex Outcome Treatment
    1