BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6000256 · Received October 5, 2016

    Report

    Report Number
    1719045-2016-10738
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 17, 2016
    Report Date
    September 17, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW COMPLETED: RELEASE TO WAREHOUSE DATE: APRIL 3, 2013 SUPPLIER: CRITERION TOOL & DIE, INC. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE DRIVE SHAFT (PART NUMBER 314.743, LOT NUMBER 7061004). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE RETURNED DEVICE WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DISTAL TIP OF THE DRIVE SHAFT WAS FOUND TO BE BROKEN AND MISSING A SEGMENT (APPROXIMATELY 13MM LONG AND 5MM IN DIAMETER). BASED ON THE COMPLAINT CONDITION, THE FAILURE OCCURRED WHILE ATTEMPTING TO REMOVE A REAMER HEAD, AS SUCH IT IS LIKELY THE TECHNIQUE UTILIZED RESULTED IN THE OBSERVED DEVICE FAILURE. THIS COMPLAINT IS CONFIRMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED. RELEVANT DIMENSIONS ON THE DISTAL END OF THE DEVICE WERE CHECKED NEAR THE BREAK AND WERE COMPARED TO THE PRINTS AT THE TIME OF MANUFACTURE AND THE RETURNED INSTRUMENT WAS FOUND TO BE WITHIN SPECIFICATION. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO NON-CONFORMANCES OR COMPLAINT RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE ROOT CAUSE MOSTLY LIKELY OCCURRED WHILE ATTEMPTING TO REMOVE A REAMER HEAD, AS SUCH IT IS LIKELY THE TECHNIQUE UTILIZED RESULTED IN THE OBSERVED DEVICE FAILURE. 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 DURING AN INTRAMEDULLARY NAIL PROCEDURE ON THE RIGHT FEMUR ON (B)(6) 2016, SURGEON WAS ATTEMPTING TO CHANGE OUT THE 12MM REAMER HEAD FOR THE 13MM REAMER HEAD AT THE BACK TABLE WHEN THE TIP OF THE REAMER/IRRIGATOR/ASPIRATOR (RIA) DRIVE SHAFT BROKE OFF. ANOTHER DEVICE WAS READILY AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. CONCOMITANT DEVICES REPORTED: 13MM REAMER HEAD-STERILE FOR RIA (PART NUMBER 352.252S, LOT UNKNOWN, QUANTITY 1). ONE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652187 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 7061004

    Patients

    Seq Age Sex Outcome Treatment
    1 REAMER HEAD(PART # 352.252S, LOT UNKNOWN, QTY 1)