BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG NAIL KIT R1.5, LEFT 10X260MM X 125

    MDR report key: 1733761 · Received June 16, 2010

    Report

    Report Number
    9610622-2010-00247
    Event Type
    Malfunction
    Date Received
    June 16, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 4, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORD (DHR)-A REVIEW OF THE DHR/INSPECTION RECORDS FOR THE LONG NAIL KIT (LOT CODE K230844) REVEALED NO DISCREPANCIES. THE ITEMS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. LIKEWISE, PACKAGING DOCUMENTS FOR THE LONG NAIL KIT REVEAL NO DISCREPANCIES. THERE HAS BEEN NO DEVIATION REPORTED REGARDING THE SET SCREW QUANTITY DURING THE PACKAGING PROCESS. DEVIATIONS IN MANUFACTURING/PACKAGING WERE NOT FOUND. IN THIS CASE VERIFICATION OF AN ALLEGEDLY MISSING SET SCREW WAS NOT POSSIBLE. IF THE SET SCREW WAS REALLY MISSING IT WOULD HAVE BEEN POSSIBLE TO DETECT THIS PRIOR TO OPENING OF THE BLISTER THROUGH THE WINDOW OF THE FOAM. ACCORDING TO THE INFORMATION AVAILABLE IT COULD NOT BE DETERMINED WHETHER THE EVENT MAY BE LINKED TO HANDLING DURING OPENING THE TYVEK LID OF THE PACKAGING OR TO A DEFICIENCY IN THE PACKAGING PROCESS.

    Description of Event or Problem · 1

    DURING THE G3 SURGERY, WHEN THE NURSE OPENED THE PACKAGE, SET SCREW WAS NOT IN PACKAGE. THE SURGEON USED A SPARE SET SCREW INSTEAD, THE SURGERY WAS COMPLETED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, LEFT 10X260MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K230844

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other