BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3200990 · Received July 2, 2013

    Report

    Report Number
    1719045-2013-01734
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT. NOT FOR DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THE DEVICE CONFORMED TO ALL REQUIREMENTS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4): CORRECT PRODUCT DEVELOPMENT EVALUATION: THE BROKEN RIA HEAD AND DRIVE SHAFT WERE FIRST NOTICED THE DAY FOLLOWING THE SURGERY AFTER THE DEVICES WERE CLEANED. THE SURGERY WAS A NAIL REPLACEMENT SURGERY, AND IT IS POSSIBLE THAT THE REAMER HEAD MAY HAVE BROKEN/DISENGAGED WHEN IT CAME INTO CONTACT WITH A SCREW PREVIOUSLY EMBEDDED IN BONE, BUT THIS COULD NOT BE VERIFIED. BECAUSE DETAILS OF THE COMPLAINT ARE STILL UNCERTAIN, THERE ARE MULTIPLE POTENTIAL CAUSES OF THIS COMPLAINT CONDITION: INCORRECT USAGE OF THE DEVICE BY INCORRECT PLACEMENT OF THE REAMING ROD LEADING TO REAMER HEAD CONTACTING METAL SCREW; DRIVE SHAFT NOT FULLY ENGAGED IN RIA TUBE ASSEMBLY AND REAMER HEAD; DISENGAGEMENT DURING USE AND INADEQUATE RE-ASSEMBLY. THE DESIGN OF THIS DEVICE HAS BEEN REVIEWED AND SHOWN TO BE ADEQUATE FOR ITS INTENDED USE. DUE TO THE MULTIPLE POTENTIAL CAUSES, THERE IS INSUFFICIENT INFORMATION IN THIS COMPLAINT TO CONCLUDE IF IT WAS CAUSED BY THE PRODUCT DESIGN DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. THE PRODUCT EVALUATION REPORTS, THE DESIGN OF THIS DEVICE HAS BEEN REVIEWED AND SHOWN TO BE ADEQUATE FOR ITS INTENDED USE. FURTHER REVIEW OF THE DESIGN RISK MANAGEMENT FILE IS BEING CONDUCTED.

    Description of Event or Problem · 1

    DURING AN IM NAIL PROCEDURE ON (B)(6) 2013, THE SURGEON WAS REAMING WITH THE REAMING IRRIGATING ASPIRATION SYSTEM. HE NOTED THAT DURING THE PROCEDURE, THE PLASTIC RIA TUBE ASSEMBLY DID NOT SEEM TO ATTACH SECURELY TO THE METAL SHAFT. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH NO EXTENSION OF TIME. AFTER THE PROCEDURE, THE RIA ASSEMBLY WAS INSPECTED AND IT WAS NOTED THAT THE TIP OF THE RIA REAMER HEAD WAS BROKEN OFF. IT IS NOT KNOWN WHEN THE TIP GOT BROKEN. THE SURGEON INDICATED THERE WAS NO EVIDENCE OF BROKEN FRAGMENT IN THE PATIENT AND THE PATIENT IS REPORTEDLY RECOVERING WELL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, THE PLASTIC RIA TUBE ASSEMBLY DID NOT SEEM TO ATTACH SECURELY TO THE METAL SHAFT. THERE WAS NO HARM TO THE PATIENT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303472 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 6877108

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR