BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM-FOR USE WITH RIA

    MDR report key: 3944212 · Received July 18, 2014

    Report

    Report Number
    1719045-2014-10316
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: CRITERION TOOL & DIE MANUFACTURED THE DRIVE SHAFT FOR USE WITH REAMING IRRIGATION ASPIRATOR (RIA). THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE INDICATES THE PARTS WERE MANUFACTURED TO AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, TABULATED INCOMING FINAL INSPECTION SHEET. NO NON-CONFORMANCE REPORTS WERE GENERATED FOR THIS LOT. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.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

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES 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 700-900RPM(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, COMPLAINT HISTORY AND RISK ANALYSIS, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. AS THE INSTRUMENT DID BREAK, THE COMPLAINT IS CONFIRMED. SPECIFIC DETAILS REGARDING THE TECHNIQUE USED/APPLICATION WHICH LED TO THE DEVICE FAILURE WERE NOT PROVIDED, HOWEVER IT IS LIKELY THAT EXCESSIVE FORCE WAS APPLIED TO THE DRILL BIT. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TIP BROKE OFF THE DRIVE SHAFT FOR USE WITH THE REAMER IRRIGATION ASPIRATOR (RIA). NO FRAGMENTS WERE REPORTED. THE PATIENT HAD AN ANKLE FUSION/BONE GRAFT FROM THE FEMUR. IT WAS UNKNOWN IF THE BREAK OCCURRED DURING THE PROCEDURE OR AFTER WHILE CLEANING THE DRIVE SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422556 DRIVE SHAFT-MINIMUM 520MM-FOR USE WITH RIA REAMER, ACCESSORIES, ARTHROSCOPIC HTO SYNTHES MONUMENT 7061004

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR