BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 12555084 · Received September 30, 2021

    Report

    Report Number
    8030965-2021-08165
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Report Date
    September 16, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. PART: 359.219 LOT: L982608 MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: (B)(6) 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE INSERTER F/TEN (PART #: 359.219, LOT #: L982608) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED HAMMERING MARKS DUE TO THE IMPACTS WITH OTHER DEVICES USED WITH THE COMPLAINT DEVICES. FUNCTIONAL TEST: DURING FUNCTIONAL ASSESSMENT, MANY ATTEMPTS TO TURN, OPEN THE CHUCK OR RELEASE THE GRIP WERE UNSUCCESSFUL. THE ENTIRE DEVICE WAS JAMMED. THE COMPONENTS COULD NOT BE DISASSEMBLED OR LOOSEN. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED DUE TO REQUIRING DESTRUCTION OF THE DEVICE, AND DEVICE ASSEMBLY AND GEOMETRY LIMITS ABILITY TO ACCURATELY DIMENSIONALLY INSPECT DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE COMPLAINT DEVICE WAS RECEIVED HAVING ITS COMPONENTS JAMMED. ALTHOUGH NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION IT IS LIKELY THAT AN INTERNAL FAILURE OF THE COMPONENTS OCCURRED. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE TENS NAIL INTRODUCER WAS FAULTY. THIS REPORT IS FOR 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
    1456393 INSERTER FOR TI ELASTIC NAILS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH L982608 07611819096653

    Patients

    Seq Age Sex Outcome Treatment
    1