BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4583316 · Received March 9, 2015

    Report

    Report Number
    1719045-2015-10149
    Event Type
    Malfunction
    Date Received
    March 9, 2015
    Date of Event
    February 24, 2015
    Report Date
    February 24, 2015
    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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT CRITERION TOOL & DIE, INC. MANUFACTURED THE DRIVE SHAFT ASSEMBLY FOR RIA, P/N 314.743, AND LOT #5682359 (SUPPLIER LOT #15175-01) ON PO #781785, FOR 11 PIECES DELIVERED JANUARY 2, 2008. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED DECEMBER 26, 2007, AND WAS INSPECTED AND CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET # 314IF741, REVISION ¿J¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON JANUARY 21, 2008. THERE WERE NO MRR¿S, NCR¿S, 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SUBJECT DEVICE WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 PRODUCT DEVELOPMENT INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE COMPLAINT CONDITION IS CONFIRMED SINCE THE DRIVE SHAFT WAS RECEIVED WITH THE DISTAL TIP BROKEN OFF. THE DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. SPECIFIC DETAILS REGARDING THE TECHNIQUE USED/APPLICATION WHICH LED TO THE DEVICE FAILURE WERE NOT PROVIDED, HOWEVER IT IS MOST PROBABLE THAT USE OF AN INCORRECT DRIVE UNIT HAS REPEATEDLY OVER TORQUED THE DRIVE SHAFT TIP CAUSING FATIGUE AND ULTIMATELY THE FRACTURE AT THE DISTAL TIP. FURTHER EVALUATION SHOWS THAT, DURING USE, THE DRIVE SHAFT IS ATTACHED TO THE CORRESPONDING LENGTH RIA TUBE ASSEMBLY AND A REAMER HEAD AND THEN CONNECTED TO A DRIVE UNIT. THE RIA SYSTEM IS INTENDED FOR USE TO CLEAR THE MEDULLARY CANAL OF BONE MARROW AND DEBRIS, TO SIZE THE MEDULLARY CANAL FOR IMPLANTS OR PROSTHESIS, TO HARVEST BONE AND BONE MARROW, AND TO REMOVE INFECTED AND NECROTIC BONE IN THE TREATMENT OF OSTEOMYELITIS. THIS INFORMATION IS PROVIDED PER WITH REAMER/IRRIGATOR/ASPIRATOR (RIA) TECHNIQUE GUIDE, J4352-H. THE RETURNED DRIVE SHAFT WAS RECEIVED WITH THE DISTAL TIP, WHICH MATES WITH THE REAMER HEAD, BROKEN OFF. THE BREAK IS LOCATED APPROXIMATELY 6.5MM DISTAL TO THE DISTAL TRANSITION TO THE DRIVE SHAFT HELIX. THE BROKEN TIP, APPROXIMATELY 15MM, WAS NOT RETURNED. THE DRIVE SHAFT HELIX SHOWS SIGNIFICANT WEAR, SCRAPES, AND FLATTENING OF THE RAISED HELIX. THE BALANCE OF THE DEVICE SHOWS WEAR AND IS IN OTHERWISE GOOD CONDITION. THUS, THE COMPLAINT CONDITION IS CONFIRMED BUT CANNOT BE REPLICATED. SPECIFIC DETAILS REGARDING THE TECHNIQUE USED/APPLICATION WHICH LED TO THE DEVICE FAILURE WERE NOT PROVIDED, HOWEVER IT IS MOST PROBABLE THAT USE OF AN INCORRECT DRIVE UNIT HAS REPEATEDLY OVER TORQUED THE DRIVE SHAFT TIP CAUSING FATIGUE AND ULTIMATELY THE FRACTURE AT THE DISTAL TIP. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. 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 BY A SALES CONSULTANT THAT A REAMER ROD BROKE DURING SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY IN SURGERY. THERE WERE FRAGMENTS GENERATED. THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION AND NO HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REGARDING THE COMPLAINED EVENT WAS RECEIVED ON (B)(6) 2015. THE PATIENT'S INITIAL SURGERY WAS PERFORMED ON (B)(6) 2014. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE (UNSPECIFIED) ON (B)(6) 2015 DURING WHICH THE REAMER BROKE DURING SURGERY. THIS FOLLOW UP REPORT #1 IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162605 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 15175-01

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR