BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMR SHOULDER, FINNED STEM DIA.23MM

    MDR report key: 3289031 · Received August 1, 2013

    Report

    Report Number
    3008021110-2013-00014
    Event Type
    Other
    Date Received
    August 1, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 1, 2013
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K101263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE DHR RELATED TO THE PACKAGING PROCESS OF THIS STEM (BATCH 201102716-1100283), WITHOUT FINDING ANY ANOMALY. BY THE EVENT DESCRIPTION, WE BELIEVE THAT THE RUBBING OF THE STEM COULD HAVE BEEN CAUSED BY BAD HANDLING DURING THE TRANSPORTATION PHASES OF THE DEVICE FROM (B)(4) TO (B)(6). IT'S LIKELY THAT WE WILL RECEIVED THE PACKAGE OF THE STEM, WE WILL SUBMIT A FOLLOW-UP REPORT AFTER ANALYZING THE PACKAGE.

    Description of Event or Problem · 1

    THIS IS A SIGNALING REGARDING THE PACKAGING OF A SMR STEM, THE EVENT OCCURRED IN (B)(6). DURING SURGERY, THE SCRUB NURSE DETECTED A RUBBING OF THE STEM AGAINST THE PLASTIC OF THE INNER VACUUMED POUCH. THE OUTER AND INNER POUCHES WERE INTACT. THE PACKAGED WAS INSPECTED FOR DAMAGE AND PUNCTURE HOLES WERE NOT IDENTIFIED. AS THE STERILITY OF THE DEVICE WAS NOT COMPROMISED, THE SURGEON WAS HAPPY TO USE THE IMPLANT. THERE WERE NO CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361364 SMR SHOULDER, FINNED STEM DIA.23MM KWT, HSD KWT LIMACORPORATE S.P.A. 1304.15.230 201102716-1100283

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization