BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-M 2.0MM BEADED CABLE SET SS

    MDR report key: 3140337 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01817
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDQ
    PMA / PMN Number
    K971741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A BROKEN DALL MILES 2.0 CABLE WAS REPORTED. THE EVENT WAS CONFIRMED. MATERIAL ANALYSIS INDICATED MOST OF THE STRANDS OF THE CABLE HAVE BEEN CUT USING A TOOL. THE TOOL USED IS UNCLEAR. NO PATIENT INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT MOST OF THE STRANDS IN THE DALL MILES CABLE HAVE BEEN CUT WITH A TOOL. THE TOOL THAT WAS USED IS UNCLEAR. THE SURGICAL PROTOCOL STATES, ¿DO NOT USE AN ORDINARY WIRE CUTTER BECAUSE A LONG TAG MAY BE LEFT AND MAY CAUSE SOFT TISSUE IRRITATION.¿ SINCE THE WIRE HAS BEEN CUT, AND DID NOT BREAK OR FRACTURE, THE EVENT IS USER RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CERCLAGE WRENCHED OFF DURING SURGERY. THERE WAS A DELAY OF 10 MIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CERCLAGE WRENCHED OFF DURING SURGERY. THERE WAS A DELAY OF 10 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242221 D-M 2.0MM BEADED CABLE SET SS IMPLANT JDQ STRYKER ORTHOPAEDICS-MAHWAH 42751006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other