BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3073396 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-01207
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE RETURNED RIA SHAFT DEVICE WAS MANUFACTURED IN JUNE 2006 AND IS OVER 6 YEARS OLD. THE REAMER WAS NOT RETURNED FOR EVALUATION. IT APPEARS THAT THE RIA SHAFT DEVICE MAY HAVE BEEN FORCED OFF-AXIS ONCE CONNECTED TO THE REAMER, CAUSING DAMAGE TO THE REAMER SHAFT. THE MATERIAL OF THE DRIVE SHAFT IS NITINOL, WHICH IS ESSENTIAL TO THE FLEXIBILITY OF THE DRIVE SHAFT. THIS IS AN ADEQUATE MATERIAL FOR THE DRIVE SHAFT. THERE ARE NO FINISHING PROCESS OR OTHER TREATMENTS THAT CAN IMPROVE THE PERFORMANCE OF THE SHAFT. OTHER DESIGNS HAVE BEEN CONSIDERED, BUT THE CURRENT DESIGN HAS BEEN DETERMINED TO BE ADEQUATE. REVISION E OF THE DESIGN CLINICAL RISK MANAGEMENT DOCUMENT WAS REVIEWED. THIS COMPLAINT IS ASSOCIATED WITH LINE 7 FOR A DRIVE SHAFT FAILURE. THE RATE OF OCCURRENCE FOR A DRIVE SHAFT FAILURE IS 1 AND IS CONTROLLED BY THE TECHNIQUE GUIDE AND IN-SERVICES FOR END USERS. THE SEVERITY OF THIS RISK IS SET AT 2, MARGINAL - EFFECT CAUSES MODERATE NUISANCE TO USERS OR PATIENTS, NOT SERIOUS ENOUGH TO CAUSE INJURY OR DAMAGE BUT MAY RESULT IN UNSCHEDULED SURGERY. THE DESIGN AND CLINICAL RISK MANAGEMENT DOCUMENT IS BEING UPDATED TO REFLECT THE CURRENT OCCURRENCE RATE REFLECTED BY THE 5-YEAR COMPLAINT HISTORY AND SALES FIGURES IN THE US AND (B)(4). (B)(4). THE SEVERITY OF THE RISK IS ALSO BEING INCREASED, AS MATERIAL LEFT IN THE PATIENT SIGNIFIES A MODERATE 3 SEVERITY OF THE RISK. THIS IS DETERMINED BECAUSE THE RISK TYPICALLY WOULD NOT PERMANENTLY IMPAIR BODILY FUNCTIONS OF THE PATIENT, BUT COULD CAUSE INJURY, ELONGATION OF OR TIME, AND USE OF ANOTHER INSTRUMENT. IT APPEARS THAT THE DEVICE MAY HAVE BEEN FORCED OFF-AXIS ONCE CONNECTED TO THE REAMER, CAUSING DAMAGE TO THE REAMER SHAFT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ADDITIONAL PRODUCT CODES - HRX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2013, WHILE SURGEON WAS USING A REAMER IRRIGATOR ASPIRATOR (RIA) TO HARVEST BONE GRAFT FROM THE RIGHT FEMUR, THE REAMER HEAD BECAME DISENGAGED FROM THE DRIVE SHAFT AND THE DRIVE SHAFT BROKE AT THE TIP. BOTH THE REAMER TIP AND THE DRIVE SHAFT WERE REMOVED FROM THE FEMUR. SURGEON USED A DIFFERENT DRIVE SHAFT TO FINISH THE PROCEDURE. THE SURGERY WAS DELAYED BY MORE THAN 15 MINUTES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173641 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA HTO SYNTHES MONUMENT 14382-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention