BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 5 RECIPROCATING SAW

    MDR report key: 1812111 · Received August 12, 2010

    Report

    Report Number
    1811755-2010-00923
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE ONCE THE DEVICE IS RETURNED FOR EVALUATION AND AN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE RECIPROCATING SAW WHICH WAS BEING USED LEAKED A BLACK FLUID INTO WOUND SITE. THIS OCCURRED WHILE MAKING THE INITIAL CUT OF THE HEAD OF THE HIP JOINT, THE WOUND SITE WAS IRRIGATED WITH ANTIBIOTICS. IT WAS ALSO REPORTED THAT THE BLADE BROKE AT THE MOUNT AND FELL INTO THE SURGICAL SITE. THE BLADE WAS ABLE TO BE REMOVED AND ANOTHER BLADE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 RECIPROCATING SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other