BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA PRECISION K WIRE BLUNT

    MDR report key: 2894509 · Received December 27, 2012

    Report

    Report Number
    9617544-2012-00599
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT HISTORY ANALYSIS, LABELING REVIEW AND RISK ASSESSMENT. RESULTS: A THROUGH INVESTIGATION COULD NOT BE PERFORMED DUE TO THE UNAVAILABILITY OF THE IMPLICATED DEVICE. COMPLAINT HISTORY ANALYSIS: (B)(4) PREVIOUS RECORDS HAVE BEEN RECEIVED. THE INVESTIGATIONS INTO PAST COMPLAINTS CONCLUDED THAT THE FAILURES WERE THE RESULT OF USER-ERROR. THE SURGICAL TECHNIQUE CLEARLY STATES THAT K-WIRE GUIDE TUBE SHOULD BE USED TO PREVENT THE K-WIRE GUIDE TUBE SHOULD BE USED TO PREVENT K-WIRE FROM BENDING OR MOVING DURING INSERTION. IN THAT CASE, THE SURGEON DID NOT USE THE K-WIRE GUIDE TUBE DURING K-WIRE INSERTION. RISK ASSESSMENT: THE BROKEN FRAGMENT WAS REMOVED. THERE WAS A DELAY IN SURGERY OF APPROXIMATELY 5 MINUTES AS A RESULT OF THE FAILURE. CONCLUSION: THE INSTRUMENT FAILURE IS BELIEVED TO BE THE RESULTS OF USER-ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "K-WIRE BECAME LODGED IN A SCREW. UPON MANTIS SCREW INSERTION, THE K-WIRE WOULD NOT PULL BACK OUT OF THE SCREW. IT DIDN'T APPEAR THAT THE WIRE WAS OVER BENT AND THE SCREW WAS NOT "CLOGGED" BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA PRECISION K WIRE BLUNT INSTRUMENT NKB STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK