BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3731946 · Received April 7, 2014

    Report

    Report Number
    1719045-2014-10119
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED: CRITERION TOOL & DIE, INC. MANUFACTURED THE DRIVE SHAFT, MINIMUM 520MM LENGTH, FOR USE WITH THE REAMER IRRIGATOR ASPIRATOR (RIA). THE CERTIFICATE OF COMPLIANCE INDICATES THE LOT WAS MANUFACTURED AND CONFORMED TO SPECIFICATIONS, PER THE SYNTHES TABULATED DRAWING. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION TABULATED SHEET. THERE WERE NO COMPLAINT-RELATED ISSUES, MATERIAL REVIEW REPORTS, OR NON-CONFORMANCE REPORTS ASSOCIATED WITH THIS LOT. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THIS DEVICE WAS RECEIVED WITH THE DISTAL WORKING AREA COMPLETELY BROKEN OFF. THE BROKEN PIECES WERE RETURNED. THE ENTIRE SHAFT HAS LIGHT CIRCUMFERENTIAL SCORE MARKS. THIS INSTRUMENT WAS MANUFACTURED ON 8/7/07. THE RIA DRIVE SHAFT, STERILE TUBE AND REAMER HEAD ARE USED IN CONCERT WITH THE SYNTHES RIA. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:DEVICE IS AN INSTRUMENT, IS NOT IMPLANTED OR EXPLANTED.A REVIEW OF DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.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 IS REPORTED THAT A DRIVE SHAFT BROKE DURING SURGERY. THE SURGEON WAS PERFORMING AN OPEN REDUCTION INTERNAL FIXATION OF A DISTAL TIBIA AND WHILE TAKING A BONE GRAPH USING AN RIA, NOTICED THE DEVICE WAS NOT WORKING PROPERLY. THE SURGEON INSPECTED THE RIA AND NOTICED THAT THE TIP OF THE DRIVE SHAFT HAD BROKEN. SURGERY WAS DELAYED FOR 15 MINUTES DUE TO THE SURGEON ENSURING THAT THERE WERE NO PIECES OF THE INSTRUMENT INSIDE THE PATIENT. IT WAS REPORTED THAT ALL THE PIECES WERE RETAINED AND NOT IN THE PATIENT.THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207482 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 15685-01

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR