BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM FLEXIBLE MEDULLARY REAMER/FLA WIRE/385MM

    MDR report key: 3003411 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10281
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEB 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MFG INVESTIGATION REVEALED THE HEADPIECE HAS BEEN SEVERELY DAMAGED, DEEP MARKS AND NICKS ON THE CUTTING SURFACES; MARKS ALONG THE DIAMETER WHERE THE HEADPIECE CONNECTS TO THE SHAFT. THE END AND THE TANG PORTIONS OF THE SHAFT EXHIBIT DAMAGE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THE EVAL, AND THE UNK CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MFG POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REAMING FOR A FRACTURED TIBIA, THE FLEXIBLE MEDULLARY REAMER DISENGAGED FROM THE REAMING SHAFT. SURGEON USED A BALL TIP GUIDE WIRE TO RETRIEVE THE REAMER AND USED A SMALLER REAMER TO COMPLETE THE PROCEDURE. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87408 7.0MM FLEXIBLE MEDULLARY REAMER/FLA WIRE/385MM HTO SYNTHES MONUMENT 6318163

    Patients

    Seq Age Sex Outcome Treatment
    1