BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, AO, STERILE ?4, 2X340MM

    MDR report key: 1905498 · Received November 10, 2010

    Report

    Report Number
    9610622-2010-00474
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 16, 2010
    Report Date
    October 18, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: REVIEW OF DEVICE HISTORY RECORD (DHR) / REVIEW OF INSPECTION RECORDS. A REVIEW OF THE INSPECTION RECORDS FOR THE DRILL, AO, STERILE ?4, 2 X 340 MM (LOT CODE K185149) REVEALED NO DISCREPANCIES. RELEVANT DIAMETERS OF THE DRILL ARE WITHIN SPECIFIED PARAMETERS. APPEARANCE OF THE BREAKAGE SURFACE AND THE ABSENCE OF PLASTIC DEFORMATION INDICATE A BRITTLE BREAK OF THE DEVICE DUE TO OVERLOAD MOST LIKELY BY BENDING STRESSES. THE VISIBLE DENTS AT THE CUTTING EDGES ARE EVIDENCES FOR CONTACT OF THE DRILL WITH OTHER HARD (METALLIC-) MATERIAL. ACCORDING TO THE EVENT DESCRIPTION, THE DRILL MISSED THE NAIL HOLE. SO WE ASSUME THAT THE DRILL HAD CONTACT WITH THE NAIL SURFACE AND THE DEVICE BROKE. MOST LIKELY CONTRIBUTED BY BENDING STRESSES DURING THE DRILLING. THE EVENT WAS NOT CAUSED BY ANY DEFICIENCY OF THE DEVICE. MANUFACTURING OR MATERIAL FAULTS WERE NOT FOUND. EVAL REVEALED EVIDENCE THAT THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICES BUT RATHER RELATED TO A USE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED, WHEN PUTTING IN THE RECON ANTEGRADE MODE, WE WERE DRILLING IN THE DRILL BIT AND THE DRILL BIT MISSED THE HOLE IN THE NAIL AND BROKE OFF IN THE PT. IT WAS LEFT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL, AO, STERILE ?4, 2X340MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K185149

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other