BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 3944595 · Received July 18, 2014

    Report

    Report Number
    2520274-2014-12706
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HTO
    PMA / PMN Number
    PK013527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT WHILE HARVESTING BONE GRAFTS FROM THE LEFT HUMERUS, THE SURGEON DISCONNECTED THE TUBING FROM THE REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM WHILE IN THE HUMERUS SHAFT. WHEN HE WENT TO RECONNECT THE TUBING, THE KIT WAS FORCED FORWARD AND THE RIA DRIVE SHAFT WITH HEXAGONAL RECESS IN THE REAMER HEAD SNAPPED. THE SURGEON USED A REAMING ROD TO RETRIEVE THE BROKEN SHAFT TIP AND RIA REAMER. A SLIVER OF BROKEN SHAFT WAS CONFIRMED TO BE REMAINING IN THE HUMERAL SHAFT VIA X-RAY. THERE WAS NO DELAY IN THE PROCEDURE AS THE SURGEON HAD ALREADY GATHERED ENOUGH BONE GRAFT BUT WAS TRYING TO OBTAIN JUST A LITTLE MORE WHEN THE SHAFT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT STATUS/OUTCOME IS REPORTED AS FINE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422949 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention