BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA

    MDR report key: 4100027 · Received September 18, 2014

    Report

    Report Number
    1719045-2014-10452
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 22, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES: HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE HEX TIP OF THE RIA DRIVE SHAFT IS BROKEN OFF ABOUT 5MM INSIDE THE HELIX. THE RIA SYSTEM IS INTENDED TO CLEAR THE MEDULLARY CANAL OF BONE MARROW AND DEBRIS, SIZE THE MEDULLARY CANAL FOR IMPLANTS OR PROSTHESIS, AND TO HARVEST BONE AND BONE MARROW IN THE TREATMENT OF OSTEOMYELITIS. THE CONDITION OF THE RETURNED DRIVE SHAFT IS CONSISTENT WITH DAMAGE CAUSED BY THE DEVICE BEING OVER TORQUED. IT IS CRITICAL FOR THE RELIABLE FUNCTION OF THE DRIVE SHAFT THAT A CANNULATED DRIVE UNIT THAT DELIVERS ONLY 3.5-4.5NM OF TORQUE AND 700-900 RPM(STD. DRILL SPEED)BE USED. THE TECHNIQUE GUIDE (J4352-H) RECOMMENDS THAT NO REDUCTION DRIVE OR DRILLS WITH A TORQUE GREATER THAN 6NM BE USED. COMPETITORS¿ DEVICES WITH A TORQUE OF UP TO 17NM ARE ROUTINELY USED. POWER EQUIPMENT DESIGNED SPECIFICALLY FOR REAMING MUST NOT BE USED. IT IS POSSIBLE THAT USE OF AN INCORRECT DRIVE UNIT HAS REPEATEDLY OVER TORQUED THE DRIVE SHAFT TIP CAUSING FATIGUE AND ULTIMATELY THE FRACTURE AT THE TIP. DRAWINGS 314_741 REV. K AND DRAWING 314_741_1_2 REV. B WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN AND APPLICATION. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS AND COMPLAINT HISTORY THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INSTRUMENT DID BREAK, SO THE COMPLAINT IS CONFIRMED. SPECIFIC DETAILS REGARDING THE TECHNIQUE AND EQUIPMENT USED WHICH LED TO THE DEVICE FAILURE WERE NOT PROVIDED, HOWEVER IT IS LIKELY THAT EXCESSIVE TORQUE WAS APPLIED TO THE DRIVESHAFT. AS THE COMPLAINT CONDITION IS THE RESULT OF METHOD OF USE RATHER THAN A DESIGN DEFICIENCY, THE DEVICE IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.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 ON (B)(6) 2014 THE SHAFT OF A REAMER/IRRIGATOR/ASPIRATOR BROKE OF DURING SURGERY. THE SURGEON REPORTED THAT HE HAD TO PUSH DOWN WHILE REAMING THE CANAL. THE FRAGMENTS WERE EASILY REMOVED WITHOUT ANY SURGICAL DELAY. PATIENT AND SURGICAL OUTCOME REPORTED AS; FINE. THIS REPORTS IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577796 DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 7081941

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR