BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 16380660 · Received February 15, 2023

    Report

    Report Number
    8030965-2023-01898
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07611819499188
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    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. ONLY THE EVENT YEAR IS KNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. PART #: 03.010.523; LOT #: 9150385; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: 17 DEC 2014. EXPIRATION DATE: N/A. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT DRIVING CAP F/INSERTION HANDLE WAS BROKEN FROM THE DISTAL TIP, FRAGMENT IS STUCK IN THE INSERTION HOLE OF THE MATING DEVICE INSERT-HANDLE RADIOLUC FEM RECON NAIL AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR DRIVING CAP F/INSERTION HANDLE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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, A FOLLOW-UP 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. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED ARAB EMIRATES AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE THREADED DRIVING CAP BROKE FROM THE THREADED TIP INSIDE THE INSERTION HANDLE WHILE APPLYING THE HAMMER FOR NAIL INSERTION. THE DEVICES WERE FROM THE FRNA SYSTEM. THERE WAS NO DELAY DUE TO THE EVENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE FRAGMENTS GENERATED, AND THEY WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT A SIMILAR INCIDENT OCCURRED IN ANOTHER PROCEDURE ON AN UNKNOWN DATE. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE SECOND INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317677 DRIVING CAP/THREADED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 9150385 07611819499188

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown INSERT-HANDLE RADIOLUC FEM RECON NAIL