BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENT

    MDR report key: 104515 · Received June 20, 1997

    Report

    Report Number
    104515
    Event Type
    Malfunction
    Date Received
    June 20, 1997
    Date of Event
    May 27, 1997
    Report Date
    June 2, 1997
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT TOTAL HIP REPLACEMENT THE BATTERY POWERED STRYKER RECIPROCATING SAW EXPELLED A BLACK OILY SUBSTANCE. THE SUBSTANCE SPRAYED ONTO THE RIGHT FEMUR AREA OF THE PT AND ONTO 2 MAYO TRAYS. THERE WAS A 30 MIN. EXTENSION OF THE CASE AND ANESTHESIA TIME. PT TREATMENT: IRRIGATION OF EXPOSED AREA WITH 3000 CC NS WITH SIMPULSE AND 2000 CC ANTIBIOTIC SOLUTION INFECTION CONTROL NOTIFIED. PT WILL BE MONITORED FOR INFECTION. PT HAS HAD NO ADVERSE REACTION TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENT BATTERY POWERED RECIPROCATING SAW HWE STRYKER INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other