BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 7 STERNUM SAW

    MDR report key: 3373896 · Received September 27, 2013

    Report

    Report Number
    0001811755-2013-02332
    Event Type
    Injury
    Date Received
    September 27, 2013
    Date of Event
    September 11, 2013
    Report Date
    September 11, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION, SO THE REPORTED EVENT COULD NOT BE CONFIRMED IN THIS CASE. NO FAILURES WERE CONFIRMED AS THE PRODUCT IN THIS INVESTIGATION WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER ACCOUNT THERE WAS NO MALFUNCTION OR PROBLEM WITH THE PRODUCT. ACCORDING TO A REVIEW OF RISK DOCUMENTATION, POSSIBLE CAUSES FOR THE REPORTED EVENT COULD RELATE TO HUMAN FACTORS OR ERRORS. CORRECTION: THE HEALTHCARE FACILITY ((B)(6) CLINIC (B)(6)) INCLUDED IN THE INITIAL REPORT WAS ENTERED IN ERROR. IT HAS SINCE BEEN CORRECTED. THE CORRECT FACILITY IS (B)(6) HOSPITAL IN (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 STERNUM SAW WAS USED IN A CARDIO-THORACIC PROCEDURE DURING A PRODUCT TRIAL AT THE USER FACILITY. WHILE THE SURGEON WAS OPENING THE STERNUM, HE ACCIDENTALLY ALSO OPENED THE PATIENT'S PLEURA. PROCEDURAL DELAY AND MEDICAL INTERVENTION WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 STERNUM SAW WAS USED IN A CARDIO-THORACIC PROCEDURE DURING A PRODUCT TRIAL AT THE USER FACILITY. WHILE THE SURGEON WAS OPENING THE STERNUM, HE ACCIDENTALLY ALSO OPENED THE PATIENT'S PLEURA. PROCEDURAL DELAY AND MEDICAL INTERVENTION WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 STERNUM SAW WAS USED IN A CARDIO-THORACIC PROCEDURE DURING A PRODUCT TRIAL AT THE USER FACILITY. WHILE THE SURGEON WAS OPENING THE STERNUM, HE ACCIDENTALLY ALSO OPENED THE PATIENT'S PLEURA. PROCEDURAL DELAY AND MEDICAL INTERVENTION WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488873 SYSTEM 7 STERNUM SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) STERNUM BLADE GUARD