BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 12377926 · Received August 27, 2021

    Report

    Report Number
    8030965-2021-07281
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Report Date
    June 7, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07611819096653
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: REPORTER IS A SYNTHES EMPLOYEE. PART: 359.219, LOT: 9424102, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: JUNE 23, 2015. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE INSERTER F/TEN (P/N: 359.219, LOT #: 9424102) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE 3 JAW SEGMENTS AND JAW GUIDE WERE RECEIVED DISASSEMBLED FROM THE DEVICE. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: DURING FUNCTIONAL TEST, THE COMPRESSION SPRING WAS OBSERVED TO BE MISSING AND AN ATTEMPT TO ASSEMBLE THE DEVICE WAS NOT SUCCESSFUL. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED AS THE INTERNAL COMPONENTS WERE INACCESSIBLE WITHOUT DESTRUCTION OF THE DEVICE AND DUE TO MISSING COMPONENTS. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. EINSCHLAGINSTRUMENT KPL . COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED WAS FELL APART AND MISSING COMPONENTS. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE INSERTER F/TEN. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO DEVICE INCORRECTLY ASSEMBLED DURING STERILIZATION PROCESS. 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 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 AN UNKNOWN DATE, THE TENS NAIL INTRODUCER WAS FOUND TO BE FAULTY. THIS REPORT INVOLVES ONE (1) INSERTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275778 INSERTER FOR TI ELASTIC NAILS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 9424102 07611819096653

    Patients

    Seq Age Sex Outcome Treatment
    1