BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X25 FINAL TIGHTENER

    MDR report key: 12635952 · Received October 14, 2021

    Report

    Report Number
    1526439-2021-02180
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 16, 2021
    Report Date
    September 16, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWR
    UDI-DI
    10705034199030
    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

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR MMSI SINGLE INNIE X25 HEX WAS CONDUCTED IDENTIFYING THAT LOT NUMBER GM4065504 WAS RELEASED IN A SINGLE BATCH. BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON MAY 2, 2014 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. VISUAL INSPECTION: THE X25 FINAL TIGHTENER (P/N: 279712600, LOT #: GM4065504) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION OF THE COMPLAINT DEVICES, THE TIP OF THE DEVICE WAS OBSERVED TO BE STRIPPED/WORN OUT. THE RECEIVED CONDITION OF THE DEVICES IS CONSISTENT AS AN END-OF-LIFE INDICATOR FOR THE DEVICES. NO OTHER ISSUES WERE IDENTIFIED DURING THE INSPECTION. THE STRIPPED CONDITION OF THE DEVICE CONTRIBUTED TO THE DEVICE INTERACTION ISSUE, SO THE COMPLAINT WAS CONFIRMED. CONCLUSION: AFTER A VISUAL INSPECTION, IT IS DETERMINED THAT THE REUSABLE INSTRUMENTS ARE WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: D9. DATE DEVICE RETURNED TO MANUFACTURER. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A PROCEDURE, THE TIP OF THE SCREWDRIVER STRIPPED. NO FRAGMENTS WERE CREATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER AVAILABLE INSTRUMENT. THERE WAS NO SURGERY DELAY AND NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) X25 FINAL TIGHTENER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533061 X25 FINAL TIGHTENER DRIVER, PROSTHESIS HWR MEDOS INTERNATIONAL SàRL CH 279712600 GM4065504 10705034199030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown