BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLLOW REAMER-COMPLETE FOR 4.5MM SCREWS

    MDR report key: 2840907 · Received November 20, 2012

    Report

    Report Number
    2520274-2012-03293
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    March 17, 2009
    Report Date
    March 27, 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): DEVICE IS EXEMPT. 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 THE TEETH ON THE CROWN DRILL BIT BROKE DURING TOTAL HIP REPLACEMENT. THE TEETH WERE UNABLE TO BE RETRIEVED FROM THE PATIENT. THE PRODUCT HAS BEEN RETAINED BUT THERE IS A RISK OF MIGRATION TO THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLOW REAMER-COMPLETE FOR 4.5MM SCREWS HOLLOW REAMER HTO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention