BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA DRIVESHAFT L520

    MDR report key: 3662311 · Received March 6, 2014

    Report

    Report Number
    2520274-2014-10112
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HTO
    PMA / PMN Number
    PK013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IT IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS; AN OPEN REDUCTION INTERNAL FIXATION OF A NON UNION LEFT TIBIA WAS PERFORMED, ALSO HARVESTING BONE GRAFT FROM FEMUR WITH REAMER IRRIGATOR ASPIRATOR SYSTEM FOR NON UNION. A DEMINERALIZED BONE MATRIX WAS USED WITH BONE GRAFT. THE DRIVE SHAFT SNAPPED OFF AT TIP WITH REAMER HEAD. THE DRIVE SHAFT REMAINED INSIDE THE PLASTIC DRIVE SHAFT TUBE. THE PART WAS PUT BACK ON THE LOANER SET; HOWEVER ITS NO LONGER USABLE. THE PRODUCT OCCURRENCE NOT RELEVANT TO THE HEALTH OF PATIENT OR USER. THIS REPORT IS FOR 1 OF 1 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134655 RIA DRIVESHAFT L520 REAMER HTO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR