BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520 MM LENGTH-FOR USE WITH

    MDR report key: 3003452 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10140
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 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. LOT NUMBER PROVIDED IS INVALID. DHR REVIEW WAS PERFORMED ON 2 ALTERNATE LOTS WITH NO COMPLAINT RELATED ISSUES NOTED. VISUAL EXAMINATION REVEALED THE RIA DRIVE SHAFT WAS RETURNED WITH THE TIP BROKEN ON THE HEX FEATURE. NO FLAT AREAS OF THE HEX REMAINS, ONLY THE LEAD-IN FEATURE. COLLAR HAS DENTS AND SCRATCHES AND SHAFT HAS AXIAL SCRATCHES INDICATING USAGE. SINCE IT CANNOT BE DETERMINED WHEN AND HOWE THE TIP BECAME DAMAGED, THIS COMPLAINT IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED, PRIOR TO A PROCEDURE, THE TIP OF THE REAMER/IRRIGATOR/ASPIRATOR DRIVE SHAFT HAD BROKEN OFF. IT IS UNKNOWN WHEN OR WHERE THIS OCCURRED. ANOTHER DRIVE SHAFT WAS USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86996 DRIVE SHAFT-MINIMUM 520 MM LENGTH-FOR USE WITH HTO SYNTHES MONUMENT 4082-0182663

    Patients

    Seq Age Sex Outcome Treatment
    1