BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECKER

    MDR report key: 5127973 · Received September 30, 2015

    Report

    Report Number
    3007208013-2015-00025
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 29, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    HAE
    UDI-DI
    00887482023440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLIER REPORT TO SYMMETRY CONFIRMED. ROOT CAUSE: WHEN OPENING AND CLOSING THE INSTRUMENTS, WE FOUND THE REMAINING JAW HINGE TO RUB AGAINST THE SHAFT, REVEALING A HEAVY ACTION. ADDITIONALLY, THE JAW HINGE IS VISIBLY BENT. BASED ON THE RESULTS OBTAINED FROM OUR EXAMINATION, WE ASSUME THE NONCONFORMANCE TO HAVE BEEN CAUSED BY A BREAKAGE AS A RESULT OF EXCESSIVE FORCE/ USER ERROR DUE TO OVERSTRESSING. WE SUSPECT THE JAW TO HAVE BEEN USED AS A LEVER OR BEEN MISUSED IN ANY OTHER WAY. SUPPLIER STATED: BASED ON THE INVESTIGATION, WE HAVE NO INDICATION WHATSOEVER THAT EITHER THE DESIGN, MATERIAL OR MANUFACTURING PROCESS, OR ANY CIRCUMSTANCES WITHIN OUR SPHERE OF INFLUENCE HAVE GIVEN CAUSE FOR ANY CORRECTIVE OR PREVENTIVE ACTION TO BE INITIATED BY U.S. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    SYMMETRY SURGICAL DID NOT RECEIVE THE DEVICE BACK; ONLY PICTURES WERE PROVIDED OF THE BROKEN DEVICE, THE PIECE THAT BROKE DURING SURGERY WAS MIS-PLACED DURING PROCESSING. SYMMETRY DID AN EVAL ON EXISTING DEVICES IN INVENTORY, SEVERAL LOTS WERE EXAMINED, AND ALL LOTS WERE REVIEWED FOR ANY DAMAGE TO THE JAWS. THEY WERE ALSO CHECKED FOR FUNCTIONALITY. ALL IN-HOUSE DEVICES WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    MICRO RONGEUR TIP BROKE OFF, NO HARM TO PT, BROKEN PIECE WAS RETRIEVED. HOSPITAL DETERMINED, THE DEVICE WAS MISUSED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644259 DECKER MICRO RONGEUR HAE SYMMETRY SURGICAL INC. 53-4000 00887482023440

    Patients

    Seq Age Sex Outcome Treatment
    1