BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3101896 · Received May 9, 2013

    Report

    Report Number
    1719045-2013-01417
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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. 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 RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DATE OF MANUFACTURER: APPROXIMATELY NOVEMBER 2005. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THE DRIVE SHAFT ¿ MINIMUM 520MM LENGTH ¿ FOR USE WITH RIA WAS MANUFACTURED BY CRITERION TOOL & DIE ON SUPPLIER LOT NUMBER 14082-01-D. THIS SUPPLIER LOT NUMBER WAS RECEIVED AS SYNTHES LOTS 5202031, 5126239, AND 5123627 FOR 2, 15, AND 22 PARTS, RESPECTIVELY. THE LOTS WERE INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THE CERTIFICATES OF COMPLIANCE ARE DATED 1/6/2006, 12/9/2005, AND 12/9/2005, RESPECTIVELY. LOT 5202031 CONFORMED TO ALL REQUIREMENTS. 2 PARTS WERE RELEASED TO WAREHOUSE ON 3/30/2006. LOTS 5126239 AND 5123627 WERE ISSUED MRR 116666 FOR SHARP EDGES AROUND THE COUPLING SLOTS THAT SHOULD HAVE BEEN BROKE TO 0.1MM MAXIMUM; 37 PARTS WERE RETURNED TO SUPPLIER FOR REWORK. THE REWORK DOCUMENTATION INDICATES THAT NORMAL MANUFACTURING PROCESSES WERE USED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WENT TO PRODUCT DEVELOPMENT FOR EVALUATION: THE RETURNED DEVICE WAS MANUFACTURED IN APPROXIMATELY NOVEMBER 2005 AND IS OVER 7 YEARS OLD. IT APPEARS THAT THE DEVICE MAY HAVE BEEN FORCED OFF-AXIS ONCE CONNECTED TO THE REAMER, CAUSING THE SHAFT TO BEND, HOWEVER NO BEND COULD BE FOUND AND NOTHING HAS BROKE OR DAMAGED THE REAMER SHAFT CONTRARY TO THE COMPLAINT CODE OF BROKE. THE MATERIAL OF THE DRIVE SHAFT IS NITINOL, WHICH IS ESSENTIAL TO THE FLEXIBILITY OF THE DRIVE SHAFT. THIS IS AN ADEQUATE MATERIAL FOR THE DRIVE SHAFT. THERE IS NOT ANY FINISHING PROCESS OR OTHER TREATMENTS THAT CAN IMPROVE THE PERFORMANCE OF THE SHAFT. OTHER DESIGNS HAVE BEEN CONSIDERED, BUT THE CURRENT DESIGN HAS BEEN DETERMINED TO BE ADEQUATE. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT HAD SURGERY TO REMOVE A COMPETITORS INTRAMEDULLARY NAIL AND A BROKEN SCREW DUE TO A DRAINING WOUND AT THE SITE OF THE LOCKING SCREW. THE INITIAL IMPLANT SURGERY TOOK PLACE APPROXIMATELY 12 TO 15 YEARS AGO. THE SURGEON REMOVED THE HARDWARE AND USED THE RIA SYSTEM TO IRRIGATE THE CANAL. NO ADDITIONAL HARDWARE WAS IMPLANTED SINCE THE FRACTURE WAS HEALED. AS THE SURGEON WAS USING THE RIA DRIVE SHAFT, THE SALES CONSULTANT NOTICED THAT THE DRIVE HUB WAS BENT CAUSING THE SHAFT TO WOBBLE. THE SURGEON WAS UNAWARE OF THE ISSUE. IT WAS REPORTED THAT THE CASE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT. POST SURGERY, THE SALES CONSULTANT TESTED THE DEVICE WITH A BATTERY AND CONFIRMED THAT IT WAS BENT AND WOBBLED. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203933 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA HTO SYNTHES MONUMENT 14082-01-D

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR COMPETITORS INTRAMEDULLARY NAIL AND SCREW