BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG NAIL KIT E2.0, STST, LEFT 11X340MM X 125

    MDR report key: 2191411 · Received July 28, 2011

    Report

    Report Number
    9610622-2011-00329
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORD (DHR) - A REVIEW OF THE INSPECTION RECORDS FOR THE LONG NAIL KIT REVEALED NO DISCREPANCIES. THE CASE WAS NOT REPRODUCIBLE BECAUSE THE BLISTER WAS ALREADY OPENED. THE CASE IS KNOWN FROM PREVIOUS PERS: MOST LIKELY THE ISSUE OCCURRED DURING TOO RAPID RIPPING OF THE TYVEK LID - WHILE THE BLISTER WAS BACK SPRINGING - SET SCREW POPPED OUT OF THE BLISTER. THIS COULD BE REPRODUCED WHEN THE TYVEK LID IS NOT OPENED CAREFULLY. DURING INVESTIGATION NO MATERIAL, DESIGN OR MFG RELATED ISSUES WERE FOUND. THE FUNCTIONALITY OF THE PACKAGE WAS TESTED SUCCESSFULLY IN AN INTERNAL LAB TEST (B)(4). DURING INVESTIGATION, NO MATERIAL, DESIGN OR MFG RELATED ISSUES WERE FOUND. EVAL REVEALED THAT THE REPORTED EVENT IS LINKED TO AN INADEQUATE USER HANDLING OF THE PACKAGE.

    Description of Event or Problem · 1

    THE PHARMACIST AT THE HOSPITAL, REPORTED THAT DURING SURGERY, WHILE OPENING THE DEVICES FROM THE STERILE PACKAGING, THE SCREW JUMP OUT AND FELL ON THE FLOOR. ANOTHER DEVICE WAS USED. THERE WAS NO DELAY AND NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT E2.0, STST, LEFT 11X340MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K587064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other