BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 2844027 · Received November 24, 2012

    Report

    Report Number
    2520274-2012-03336
    Event Type
    Injury
    Date Received
    November 24, 2012
    Date of Event
    April 3, 2009
    Report Date
    April 16, 2009
    Manufacturer
    SYNTHES
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A BROKEN INSTRUMENT. DURING THE SURGERY, THE INSTRUMENT BROKE IN THE MEDULARY CANAL OF THE PATIENT. ONE PART OF THE INSTRUMENT WAS LEFT IN THE PATIENT. THE SURGEON DID NOT NOTICE ANYTHING DURING SURGERY, AND THEY CONTINUED WITH A LARGER HEAD. THE SURGERY WENT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.5MM MEDULLARY REAMER HEAD 8.5MM MEDULLARY HTO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention