BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER Ø11 F/PFNA BLADE

    MDR report key: 2925906 · Received January 22, 2013

    Report

    Report Number
    2520274-2013-00572
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    August 26, 2009
    Manufacturer
    SYNTHES
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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.

    Description of Event or Problem · 1

    EU COMPLAINT HANDLING UNIT REPORTED A DRILL BROKE UP IN SITU. THE OPERATING TECHNIQUE WAS FOLLOWED. THE SMALL PART OF THE DRILL REMAINS IN THE PATIENT AND CAN BE SEEN ON THE ENCLOSED X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30255 REAMER Ø11 F/PFNA BLADE REAMER Ø11 F/PFNA BLADE HSB SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1