BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA DRIVESHAFT L520

    MDR report key: 2791970 · Received October 16, 2012

    Report

    Report Number
    1719045-2012-01071
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    June 13, 2012
    Report Date
    September 17, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THE DRIVE SHAFT, MINIMUM 520MM LENGTH FOR USE WITH RIA WAS MANUFACTURED BY CRITERION TOOL & DIE. THIS SUPPLIER LOT NUMBER WAS RECEIVED AND WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. LOT MET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES PERFORMED INVESTIGATION COULD NOT DETECT ANY MATERIAL FAULTS. THE PLASTIC DEFORMATIONS COMBINED WITH THE FOUND FINE DIMPLY STRUCTURE ON THE FRACTURE SURFACE ARE A CLEAR INDICATION OF A DUCTILE FORCED FRACTURE MECHANISM. IT CAN BE ASSUMED THAT THE REAMER BROKE DURING AN INSTANTANEOUS OVERLOADING. ONE POSSIBLE EXPLANATION FOR SUCH AN OVERLOADING EVENT MIGHT HAVE BEEN CONTACT WITH OTHER HARD MATERIAL SUCH AS METALLIC PARTS OR PARTICLES CAUSING A BLOCKING OF THE REAMER. ANOTHER POSSIBLE REASON FOR THE OVERLOADING MIGHT HAVE BEEN ADDITIONAL FORCE ONTO THE REAMER TO ATTEMPT COMPENSATION OF AN INSUFFICIENT DRILLING PERFORMANCE DUE TO THE DAMAGED CUTTING EDGES OR EXTENSIVE FRICTION BECAUSE OF WRONG OR BAD MOUNTING OF THE REAMER HEAD.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING THE UTILIZATION OF THE RIA DRIVE SHAFT, THE MILLING CUTTER TIP LOOSENED, RESULTING IN THE BREAKAGE OF THE INNER SHAFT. THE BROKEN FRAGMENT WAS RETRIEVED AND NO HARM TO THE PATIENT WAS NOTED. THE POST SURGERY WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIA DRIVESHAFT L520 RIA DRIVESHAFT HTO SYNTHES MONUMENT 14780-01

    Patients

    Seq Age Sex Outcome Treatment
    1