BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA PRECISION K-WIRE SHARP

    MDR report key: 2894504 · Received December 27, 2012

    Report

    Report Number
    9617544-2012-00594
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY ANALYSIS, LABELING REVIEW AND RISK ASSESSMENT RESULTS: A THOROUGH INVESTIGATION COULD NOT BE PERFORMED DUE TO THE UNAVAILABILITY OF THE IMPLICATED DEVICE. MANUFACTURING RECORD REVIEW: NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE BREAKAGE WERE REPORTED DURING THE MANUFACTURING. COMPLAINT HISTORY ANALYSIS: (B)(4) PREVIOUS RECORDS HAVE BEEN REVIEWED. THE INVESTIGATION 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 FROM BENDING OR MOVING DURING INSERTION. IN THAT CASE, THE SURGEON DID NOT USE THE K-WIRE GUIDE TUBE DURING K-WIRE INSERTION. ALSO, THERE IS NO MENTION OF ANY "CORDLESS WIRE DRIVER" IN THE MANTIS SURGICAL TECHNIQUE, HENCE, THE USAGE OF THIS INSTRUMENT IS NOT RECOMMENDED. RISK ASSESSMENT: THE BROKEN FRAGMENT REMAINED IN THE PT. THERE WAS NO ADVERSE CONSEQUENCES IN THE REPORTED EVENT. CONCLUSION: THE INSTRUMENT FAILURE IS BELIEVED TO BE THE RESULT OF USER-ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING A PERCUTANEOUS SURGERY, THE K-WIRE END BROKE OFF WHILE TRYING TO REMOVE IT THROUGH THE SCREW. THE K-WIRE WAS INSERTED WITH A CORDLESS WIRE DRIVER THROUGH A JAM SHIDI NEEDLE. THEN THE SURGEON USED AN AWL AND A TAP BEFORE INSERTING THE SCREW OVER THE K-WIRE. WHEN THE SCREW WAS THROUGH THE PEDICLE AND INTO THE BODY, THE SURGEON REMOVED THE K-WIRE WITH THE CORDLESS WIRE DRIVER AND THE TIP BROKE OFF DISTAL TO THE SCREW. THE TIP REMAINED IN THE PT POST OP. NO ADVERSE EFFECTS NOTICED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA PRECISION K-WIRE SHARP INSTRUMENTS NKB STRYKER SPINE BORDEAUX NA 059291

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR