BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW T2 SCN

    MDR report key: 2707505 · Received August 14, 2012

    Report

    Report Number
    9610622-2012-00374
    Event Type
    Malfunction
    Date Received
    August 14, 2012
    Date of Event
    August 2, 2012
    Report Date
    August 2, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN AT THIS TIME IF THE DEVICE WILL BE RETURNED FOR INVESTIGATION. IF ADD'L INFO IS REC'D IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: 1806-332 TARGET ADAPTER T2 SCN, LOT# KP215483, (B)(4) NAIL ADAPTER T2 SCN, LOT# KP280021, (B)(4) SUPRACONDYLAR NAIL T2 SCN 10X300MM LOT#284017.

    Description of Event or Problem · 1

    DURING THE T2 SCN SURGERY, THE SURGEON TRIED TO DRILL THE DISTAL SCREW HOLE (POSITION 4) OF THE NAIL WITH A 5.0MM DRILL BIT. HOWEVER, THE DRILL DID NOT PASS THE SCREW HOLE OF THE NAIL. WHEN THE NURSE CHECKED, THE DRILL WAS CONTACTING THE TIP OF THE NAIL HOLDING SCREW INSIDE THE NAIL. THEREFORE THE SURGEON LOOSENED THE NAIL HOLDING SCREW, AND DRILLED SCREW HOLE OF NAIL (POSITION 4). THE SCREW HOLE OF THE POSITION 1 AND 2 WERE ABLE TO BE DRILLED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAIL HOLDING SCREW T2 SCN INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KI589441 K953447

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other