BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER Ø11 F/PFNA BLADE

    MDR report key: 2943029 · Received February 5, 2013

    Report

    Report Number
    2520274-2013-00789
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    February 2, 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. LOT NUMBER COULD NOT BE VERIFIED. 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 OCTOBER 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

    (B)(4) COMPLAINT HANDLING UNIT REPORTED TWO REAMERS BROKE DURING THE PROCEDURES. THE TWO REAMERS WERE RETURNED- LOT 2156757. DURING TWO DIFFERENT PROCEDURES THE REAMERS BROKE AND THE REMAINS WERE LEFT IN THE TWO PATIENTS. A CLINICAL INCIDENT WAS LOGGED AT THE HOSPITALS AS PART OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49018 REAMER Ø11 F/PFNA BLADE REAMER Ø11 F/PFNA BLADE HSB SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1