BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR CHAMFER REAMER

    MDR report key: 5230567 · Received November 17, 2015

    Report

    Report Number
    0008031020-2015-00456
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    October 27, 2015
    Report Date
    October 28, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED THE ANTERIOR CHAMFER REAMER TO BE THE PRIMARY PRODUCT. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AN INVESTIGATION WAS NOT POSSIBLE BECAUSE THE REAMER WAS DISCARDED AND THEREFORE NOT AVAILABLE. THE ROOT CAUSE OF THE REPORTED ¿SNAPPED IN HALF¿ COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE E-RING GOT DETACHED DURING USAGE IN THE CUT GUIDE SLOTS. PREVIOUS COMPLAINTS ARE KNOWN REPORTING A DETACHED E-RING. DUE TO BENDING FORCES TOWARDS SUPERIOR/INFERIOR AND PUSHING THE REAMER STOP SLEEVE ONTO THE CUTTING GUIDE SURFACE IT IS POSSIBLE THAT THE E-RING GET OVERLOADED AND IS PUSHED OUT OF ITS CIRCUMFERENTIAL GROOVE. THEREFORE, IT IS FREE MOVABLE ON THE REAMER SHAFT. NOW THE SLEEVE IS NO LONGER SECURED AND IS ALSO AXIALLY MOVEABLE. WITHOUT A SECURED SLEEVE, THE REAMER WILL NO LONGER STOP AT ITS REQUIRED DEPTH AND A DEEPER REAMING INTO THE TALUS BONE IS POSSIBLE. THE IFU INCLUDES THAT THE INSTRUMENTS SHALL BE PRE-CHECKED BEFORE EVERY SURGERY REGARDING DAMAGES/DEFORMATIONS; FURTHERMORE INSTRUMENTS SHALL BE USED WITH CARE. ADDITIONALLY THE REAMER IS LABEL-MARKED AS SINGLE USE PRODUCT; A MULTIPLE-USAGE IS NOT ALLOWED. BASED ON THE GIVEN INFORMATION AND THE FACT THAT NO MANUFACTURING ISSUE WAS FOUND DURING DHR REVIEW THE CASE WAS MOST LIKELY CAUSED BY AN OVERLOAD BY THE USER. ALSO MULTIPLE USAGES CANNOT BE EXCLUDED. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(4), HOWMEDICA OSTEONICS CORP.¿S PURCHASED CERTAIN ASSETS OF SBI ON AUGUST 1, 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE WILL NOT BE RETURNED

    Description of Event or Problem · 1

    THE ANTERIOR MILL IN THE STERILE PIN PACK (100-0071) SNAPPED IN HALF AS THE DOCTOR WAS MILLING DURING A TOTAL ANKLE. THE SURGEON DECIDED TO DO IT FREEHAND AND DO FEATHERING WITH AN OSCILLATING SAW. EVENT OCCURRED DURING PRIMARY SURGERY.

    Description of Event or Problem · 1

    THE ANTERIOR MILL IN THE STERILE PIN PACK ((B)(4)) SNAPPED IN HALF AS THE DOCTOR WAS MILLING DURING A TOTAL ANKLE. THE SURGEON DECIDED TO DO IT FREEHAND AND DO FEATHERING WITH AN OSCILLATING SAW. EVENT OCCURRED DURING PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761394 ANTERIOR CHAMFER REAMER PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 1434402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other