BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3954959 · Received July 24, 2014

    Report

    Report Number
    1719045-2014-10335
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: CRITERION TOOL & DIE, INC. MANUFACTURED THE DRIVE SHAFT ¿ MINIMUM 520MM LENGTH ¿ FOR USE WITH RIA (REAMER IRRIGATOR ASPIRATOR) P/N 314.743, LOT # 6921238. THE LOT CONFORMED TO SPECIFICATIONS AND WAS MANUFACTURED TO THE RELEVANT SYNTHES DRAWING AS NOTED IN THE CERTIFICATE OF COMPLIANCE AND THE CERTIFICATE OF CONFORMANCE. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. 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 THAT 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. REVIEW OF RISK ASSESSMENT SE_145841 AC LINE 450 ADDRESSES "DRIVESHAFT FAILURE" AS A HAZARD WITH A SEVERITY OF 3 AND AN OCCURRENCE RATE OF 2 WITH "MISUSE, INCORRECT HANDLING OF SHAFT¿"AS A CAUSE. 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

    THIS IS REPORT 1 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE OPERATION OF A REAMER/IRRIGATOR/ASPIRATOR APPARATUS, THE REAMER DRIVE SHAFT BROKE IN TWO AT THE POINT WHERE THE DRIVE SHAFT MEETS THE REAMER HEAD, LEAVING THE REAMER HEAD LOOSE ON GUIDE WIRE. THE REAMER HEAD AND BROKEN SHAFT WERE RECOVERED BY PULLING BALL TIP REAMING ROD OUT. A SECOND REAMER/IRRIGATOR/ASPIRATOR APPARATUS WAS SET UP WITH A NEW DRIVE SHAFT, REAMER HEAD AND TUBE ASSEMBLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY; THE DRIVE SHAFT ON THAT ONE BROKE IN A SIMILAR FASHION. THE PROCEDURE WAS DELAYED FOR TEN MINUTES BECAUSE OF THIS INCIDENT. THE PIECES OF THE DRIVE SHAFT WERE RECOVERED AND NO PIECES WERE LEFT IN THE PATIENT. NO PATIENT HARM WAS REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434319 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 6921238

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR