BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 10X10X10MM

    MDR report key: 6146232 · Received December 5, 2016

    Report

    Report Number
    0008031020-2016-00584
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 10, 2016
    Manufacturer
    STRYKER GMBH
    Product Code
    JDR
    PMA / PMN Number
    K070031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT THAT OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 10X10X10MM WAS ALLEGED OF ISSUE S-67 (CONTAMINATION OF THE DEVICE) COULD BE CONFIRMED. SINCE A SMALL PIECE OF CARDBOARD WAS FOUND SITUATED IN THE INSIDE BLISTER OF THE PACKAGE. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A MANUFACTURING ISSUE AND THEREFORE A NC HAS BEEN OPENED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    STERILE EASY CLIP HAD DEBRIS INSIDE THE PACKAGE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795048 OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 10X10X10MM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES. JDR STRYKER GMBH V18616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other