BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR CHAMFER REAMER

    MDR report key: 8030785 · Received November 1, 2018

    Report

    Report Number
    0008031020-2018-00940
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 4, 2018
    Report Date
    January 15, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT THAT ANTERIOR CHAMFER REAMER WAS ALLEGED OF 'INSTRUMENTS - REAMER - BROKEN' COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    WHILE THE SURGEON USED THE TALAR SURFACE REAMER (100-3007) TO PREPARE THE SURFACE OF THE TALUS IN CONJUNCTION WITH THE TALAR AP CUT GUIDE, THE "COLLAR" ON THE REAMER WAS BROKEN. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT COMPLICATION, BUT UPON FINAL INSPECTION, THE REAMER, IT WAS DISCOVERED WAS BROKEN. THIS ITEM WAS USED BRAND NEW, OUT OF THE BOX, IN THE STERILE KIT (100-0071).

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    WHILE THE SURGEON USED THE TALAR SURFACE REAMER (100-3007) TO PREPARE THE SURFACE OF THE TALUS IN CONJUNCTION WITH THE TALAR AP CUT GUIDE, THE "COLLAR" ON THE REAMER WAS BROKEN. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT COMPLICATION, BUT UPON FINAL INSPECTION, THE REAMER, IT WAS DISCOVERED WAS BROKEN. THIS ITEM WAS USED BRAND NEW, OUT OF THE BOX, IN THE STERILE KIT (100-0071).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867637 ANTERIOR CHAMFER REAMER INSTRUMENT HTO STRYKER GMBH L01854

    Patients

    Seq Age Sex Outcome Treatment
    1 Other