BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDULLARY REAMER Ø8 L385

    MDR report key: 3171655 · Received June 15, 2013

    Report

    Report Number
    1719045-2013-01602
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    May 30, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION HAS SHOWN THAT THE WELD BETWEEN THE SHAFT AND REAMER IS INDEED BROKEN OFF. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE CAUSE IS UNKNOWN. SYNTHES HAS NOT HAD A SINGLE COMPLAINT REGARDING SUCH A PROBLEM, THEREFORE NO FURTHER MEASURES HAVE BEEN TAKEN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY ON AN UNKNOWN DATE, THE REAMER HEAD BROKE OFF. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272525 MEDULLARY REAMER Ø8 L385 HTO SYNTHES MONUMENT 6718398

    Patients

    Seq Age Sex Outcome Treatment
    1