BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEPTIC BATTERY HOUSING

    MDR report key: 2241575 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03281
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT RETURNED WAS REQUESTED, BUT AS OF THE DATE OF THIS REPORT THE DEVICE IS NOT AVAILABLE TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY HOUSING OPENED DURING A KNEE SURGERY AND EXPOSED THE NON-STERILE BATTERY TO BE STERILE SITE. THE BATTERY DID NOT FALL OUT INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE, AND THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. NO ADDITIONAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASEPTIC BATTERY HOUSING KIJ STRYKER INSTRUMENTS KALAMAZOO 10335

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK