BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.5MM X 10.7MM FLUTED DRUM SUPER LONG

    MDR report key: 1442843 · Received May 14, 2009

    Report

    Report Number
    9616696-2009-00067
    Event Type
    Malfunction
    Date Received
    May 14, 2009
    Date of Event
    March 31, 2009
    Report Date
    April 16, 2009
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NUMBERS 5190-020-123 LOT # 06241017 AND 5190-020-991 LOT # 06319017 ALSO ALLEGEDLY AFFECTED BY THIS POTENTIAL ISSUE. PRODUCT NOT RECEIVED AS YET FOR EVALUATION. PRODUCT RECALL INITIATED OWING TO MATERIAL DEGRADATION ISSUE. IT HAS NOT BEEN CONFIRMED AS YET IF THIS ISSUE IS RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT PACKAGING WAS CRACKED. IT WAS FURTHER REPORTED THAT THE PRODUCT LABEL INDICATES THAT THE PRODUCT IS WITHIN ITS EXPIRY DATE. PATIENT INJURY WAS NOT REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10.5MM X 10.7MM FLUTED DRUM SUPER LONG DRILLS, BURS, TREPHINES & ACCESSORIES HBF STRYKER IRELAND LTD. 07045017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK