BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 COUNTER TORQUE INSTRUMENT

    MDR report key: 3881546 · Received May 28, 2014

    Report

    Report Number
    3005673311-2014-00056
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: WELDING SEAM IS BROKEN, DUE TO MECHANICAL OVERLOAD. NO MATERIAL OR PRODUCT DEVIATION FOUND.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DURING THE FINAL TIGHTENING , THE FIRST SET SCREW COULD BE TIGHTENED PROPERLY, BUT THE PROBLEM OCCURRED AT THE SECOND SCREW TIGHTENING. WHEN THE SURGEON TRIED TO TIGHTEN THE SET SCREW, THE TORQUE HANDLE RAN IDLE EVEN THOUGH THE TORQUE WAS NOT APPLIED TO 10N. ACCORDING TO THE SURGEON, HE HEARD THE SOUND OF A CRACK. FINALLY, HE USED DIFFERENT INSTRUMENTS TO TIGHTEN THE SCREW, AND THE OPERATION WAS COMPLETED. WHEN THE CUSTOMER CHECKED THE PRODUCT VISUALLY AFTER THE SURGERY, HE FOUND THAT THE INSIDE OF THE WORKING END WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314294 S4 COUNTER TORQUE INSTRUMENT STABILIZATION INSTRUMENT LXH AESCULAP AG & CO. KG FW178R 4600000270

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other