BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEPDRILL FOR LAG SCREW T2 RECON

    MDR report key: 3212708 · Received July 9, 2013

    Report

    Report Number
    0009610622-2013-00375
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: APPEARANCE OF THE BREAKAGE SURFACE AS WELL AS THE COURSE OF THE BREAKAGE LINE SUGGESTS THAT THE DRILL BROKE IN A FORCED (BRITTLE) FRACTURE DUE TO BENDING OVERLOAD. THE EXTENT OF DAMAGE BEING OBSERVED ON THE CUTTING EDGES SUGGESTS CONTACT OF THE DEVICE TO HARD (METAL) OBJECTS. A REVIEW OF THE DHR, DIMENSIONS AND A HARDNESS TEST REVEALED NO DISCREPANCIES. BASED ON THE FOUND DAMAGE AND AS DURING THE INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND, THE REPORTED EVENT COULD BE CLASSIFIED AS NOT BEING DEVICE RELATED. THE USE OF CANNULATED STEP-DRILL IS NOT RECOMMENDED DUE TO THE NEW T2 RECON OPERATIVE TECHNIQUE ((B)(4)). THIS WAS ANNOUNCED IN APRIL 2009 WITH PRODUCT BULLETIN (B)(4)¿ ¿NEW VERSION OF T2 RECON OPERATIVE TECHNIQUE IS NOW AVAILABLE.¿ THE INFORMATION WHETHER THE BROKEN OFF PART OF THE DRILL WAS RETRIEVED FROM THE PATIENT WAS NOT PROVIDED. IT IS IN THE RESPONSIBILITY OF THE SURGEON TO DECIDE IF A BROKEN OFF PIECE FROM A DRILL HAS TO BE REMOVED OR IF IT MORE BENEFICIAL TO LET THE PIECE REMAIN IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DRILLING FOR THE 6.5MM CANNULATED SCREWS FOR THE RECON NAIL, THE TIP OF THE STEP DRILL FOR LAG SCREW, RECON (1806-3025) BROKE-OFF INSIDE THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DRILLING FOR THE 6.5MM CANNULATED SCREWS FOR THE RECON NAIL, THE TIP OF THE STEP DRILL FOR LAG SCREW, RECON ((B)(4)) BROKE-OFF INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314059 STEPDRILL FOR LAG SCREW T2 RECON INSTRUMENT LXH STRYKER TRAUMA KIEL K933833

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention