BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW STEP DRILL 10.5 X 495 MM

    MDR report key: 1082449 · Received July 22, 2008

    Report

    Report Number
    9610622-2008-00129
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 29, 2008
    Report Date
    July 8, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT. SAME PT EVENT AS MDR 9610622-2008-00130.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON INSERTED A T2 RECON NAIL. THE TARGETER WAS PUT ON, THE GUIDE SLEEVES WERE INSERTED THROUGH THE DISTAL SLEEVE, DURING INSERTION, THE TIP OF THE WIRE BROKE OFF IN THE FEMORAL HEAD. THE NEXT K-WIRE WAS INSERTED AND THE TIP BROKE OFF IN THE FEMORAL HEAD. THE NAIL WAS REMOVED AND REPLACED WITH A 11X420 RT GAMMA NAIL. THE K-WIRE WAS INSERTED INTO THE FEMORAL HEAD. THE STEPDRILL WAS INSERTED OVER THE WIRE. THERE WAS RESISTANCE MET AND THE TIP OF THE STEPDRILL BROKE OFF INTO THE FEMORAL HEAD. IT WAS REMOVED WITH THE EXTRACTOR SCREW SET. THE PROCEDURE WAS FINISHED WITH ANOTHER STEP DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW STEP DRILL 10.5 X 495 MM INSTRUMENT HTW STRYKER OSTEOSYNTHESIS KIEL NA K754789

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other