BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARC2F. CUP HOLDER

    MDR report key: 2913005 · Received January 14, 2013

    Report

    Report Number
    0002249697-2013-00035
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 2, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE CHR INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. UPON VISUAL INSPECTION THE CUP HOLDER WAS FOUND TO HAVE FRACTURED AT THE BASE OF THE DRIVER TIP. DIMENSIONAL INSPECTION OF FEATURES RELEVANT TO THE FRACTURE SITE INDICATED ALL WERE WITHIN SPECIFICATION. MAR INDICATED THAT THE DEVICE BROKE DUE TO A TORSIONAL OVERLOAD CONDITION WITH THE FRACTURE INITIATING AT MULTIPLE EDGE LOCATIONS. FINAL FRACTURE OCCURRED IN DUCTILE OVERLOAD. THE INVESTIGATION CONCLUDED THAT NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE RETURNED DEVICE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT DURING A SURGERY THE REPORTED DEVICE BROKE APART. IT WAS REPORTED THAT THERE WAS A DELAY OF 100 MINUTES AND ADDITIONAL ANAESTHESIA WAS NECESSARY.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT DURING A SURGERY THE REPORTED DEVICE BROKE APART. IT WAS REPORTED THAT THERE WAS A DELAY OF 100 MINUTES AND ADDITIONAL ANAESTHESIA WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21394 ARC2F. CUP HOLDER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G3049308

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention