BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2973621 · Received February 22, 2013

    Report

    Report Number
    1719045-2013-00404
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO MRR, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. THE LOT CONFORMED TO SPECIFICATIONS AND WAS MANUFACTURED TO THE SYNTHES DRAWING.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE ASSEMBLY WAS RECEIVED WITH A BROKEN SHAFT BUT OTHERWISE IN GOOD CONDITION. THE REAMER AND HEAD SHAFT ARE BROKEN AND THE DIMENSIONS OF THE HEX AND TIP COULD NOT BE VERIFIED. THE MATERIAL OF THE SHAFT WAS DETERMINED TO BE WITHIN SPECIFICATION. THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED FUNCTIONAL TESTING AT SYNTHES INCOMING INSPECTION. IT APPEARS THAT THE SURGEON MAY HAVE FORCED THE REAMER FORWARD DURING INITIAL REAMING, CAUSING DAMAGE TO THE REAMER SHAFT. ALSO, A STRYKER DRILL WAS USED WITH THE RIA, WHICH MAY PROVIDE EXCESS TORQUE AND STRESS. THEREFORE, THE TECHNIQUE USED MAY HAVE BEEN INCONSISTENT WITH THE TECHNIQUE GUIDE INSTRUCTION.

    Description of Event or Problem · 1

    THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TIBIAL NAIL, END CAP, AND FIVE SCREWS ON (B)(6) 2012. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REMOVAL OF HARDWARE DUE TO A NON-UNION. THE SURGEON REVISED THE PATIENT TO A PLATE CONSTRUCT AND BONE GRAFT. DURING THE REVISION SURGERY, WHILE HARVESTING BONE GRAFT WITH THE RIA SYSTEM, THE SURGEON WAS REAMING AND THE TIP OF THE DRIVE SHAFT BROKE OFF. THE DRIVE SHAFT IS IN TWO PIECES. POST X-RAYS TAKEN REVEALED TWO FRAGMENT PIECES; HOWEVER, THE TWO FRAGMENTS COULD NOT BE CONFIRMED AS METAL OR BONE. THE SURGEON USED A BACK UP REAMER TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER INCIDENT. THIS IS 8 OF 8 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77676 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA DRIVE SHAFT HTO SYNTHES MONUMENT 6921238

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR STRYKER DRILL