BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRC AWL / TAP

    MDR report key: 17855502 · Received October 2, 2023

    Report

    Report Number
    1221934-2023-03591
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 14, 2023
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705008186
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: UDI: (B)(4). D4: THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE. D4: THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE. E3: REPORTER IS A J&J SALES REPRESENTATIVE. H4: THE DEVICE MANUFACTURE 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED. VISUAL OBSERVATIONS REVEALED WEAR MARKS ON THE DEVICE, IT WAS ALSO NOTED THAT THE SHAFT AND TIP WERE DEFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT 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 ROOT CAUSE OF THE DEFORMED CONDITION CAN BE ATTRIBUTED TO TECHNIQUE ISSUE WHERE EXCESS MECHANICAL FORCE WAS APPLIED, WHICH COULD HAVE LED TO THE REPORTED FAILURE, AND THE HEAVILY USE OF THE DEVICE SINCE THIS IS A REUSABLE PART. AS PER THE INSTRUCTIONS FOR USE, INSPECT FOR DAMAGE PRIOR TO USE; AND REPLACE A DAMAGED, WORN OR BENT INSTRUMENT. ALSO, THE END OF USEFUL INSTRUMENT LIFE IS GENERALLY DETERMINED BY WEAR OR DAMAGE FROM HANDLING OR SURGICAL USE. INSPECT INSTRUMENTS BETWEEN USES TO VERIFY PROPER FUNCTIONING. FINALLY, 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. 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 SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SHAFT ON THE HEALIX TRANSTEND AWL/TAP DEVICE WAS BENT. 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
    1972067 PRC AWL / TAP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY MITEK LLC US 1511001 10886705008186

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown