BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    RECIPROCATING BLADE

    MDR report key: 13167935 · Received January 5, 2022

    Report

    Report Number
    13167935
    Event Type
    No answer provided
    Date Received
    January 5, 2022
    Date of Event
    December 1, 2021
    Report Date
    December 27, 2021
    Manufacturer
    STRYKER CORPORATION
    Product Code
    GFA
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SAW BLADE BROKE DURING AN ORTHOPEDIC CASE OF A TOTAL KNEE REPLACEMENT. SCRUB TECHNICIAN, SURGEON, RN AND CHARGE NURSE VISUALIZED BOTH PIECES OF BLADE AND PATIENT WAS INSPECTED BY SURGEON AND SCRUB TECHNICIAN. COUNT WAS COMPLETE AND CORRECT. SAW BLADE GIVEN TO MATERIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193595 RECIPROCATING BLADE BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL GFA STRYKER CORPORATION 0277096281 21126017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown