BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3123814 · Received May 22, 2013

    Report

    Report Number
    1719045-2013-01454
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    April 25, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE RETURNED RIA SHAFT DEVICE WAS MANUFACTURED IS OVER 7 YEARS OLD. 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 NOT ANY FINISHING PROCESSES 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. BECAUSE IT APPEARS THAT THE DEVICE MAY HAVE BEEN FORCED OFF-AXIS ONCE CONNECTED TO THE REAMER, CAUSING DAMAGE TO THE REAMER SHAFT, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE.

    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 ONGOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED, WHICH INDICATES THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PROCEDURE DURING WHICH THIS INCIDENT OCCURRED WAS AN OPEN REDUCTION INTERNAL FIXATION FOR A RIGHT FIBIAL SHAFT FRACTURE. THE INJURY OCCURRED ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF THE SHAFT OF A REAMER IRRIGATOR ASPIRATOR SYSTEM, AND NOW IT IS VERY DIFFICULT TO PUT THE REAMER HEAD ONTO THE DEVICE. THE BROKEN TIP WAS NOTICED DURING A PROCEDURE, AT WHICH POINT THE HEAD WAS ABLE TO BE CONNECTED TO THE SHAFT WITHOUT DELAY. HOWEVER, AFTERWARD IT HAD BECOME DIFFICULT TO ATTACH THE HEAD TO THE SHAFT. THERE WAS REPORTEDLY NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225792 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA HTO SYNTHES MONUMENT 14382-01

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR