BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM

    MDR report key: 2917747 · Received December 18, 2012

    Report

    Report Number
    9610622-2012-00594
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING SURGERY, IT WAS FOUND THAT THE PLASTIC GROMMET PROTRUDED UPON OPENING THE STERILE PACKAGE BEFORE USAGE, THUS IT COULD NOT BE ASSEMBLED WITH A REAMER. A BACK-UP ITEM WAS OPENED; HOWEVER, THE APPEARANCE WAS THE SAME AS THE FIRST ONE. ALTHOUGH THE SECOND ONE WAS MANAGED TO BE USED BY FORCE AND THE PROCEDURE WAS COMPLETED. THE TWO ITEMS WILL BE AVAILABLE FOR EVAL (THE LOT #K180395 WAS NOT USED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM IMPLANT LXH STRYKER OSTEOSYNTHESIS KIEL NA K161140/K180395

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other