BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER

    MDR report key: 4113037 · Received September 24, 2014

    Report

    Report Number
    2520274-2014-13782
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. KANAKARIS, N., MORELL, D., GUDIPATI, S., BRITTEN, S., GIANNOUDIS, P. (2011) REAMING IRRIGATOR ASPIRATOR SYSTEM: EARLY EXPERIENCE OF ITS MULTIPURPOSE USE. INJURY, INT. J. CARE INJURED 42(S4), S28-S34. THIS REPORT IS FOR AN UNKNOWN REAMER IRRIGATION ASSEMBLY DRIVE SHAFT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KANAKARIS, N., MORELL, D., GUDIPATI, S., BRITTEN, S., GIANNOUDIS, P. (2011) REAMING IRRIGATOR ASPIRATOR SYSTEM: EARLY EXPERIENCE OF ITS MULTIPURPOSE USE. INJURY, INT. J. CARE INJURED 42(S4), S28-S34. BETWEEN JANUARY 2008 TO JUNE 2009, 42 CONSECUTIVE PATIENTS WERE TREATED WITH THE SYNTHES REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM. THERE WAS ONE INTRA-OPERATIVE COMPLICATION RELATED TO THE RIA SYSTEM WITH DISMANTLING OF THE REAMER HEAD/DRIVE SHAFT CONSTRUCT DURING REAMING FOR BONE GRAFT HARVESTING. THIS PROBLEM WAS ATTRIBUTED TO POOR CONNECTION OF THE REAMER HEAD ON THE DRIVE SHAFT (USER¿S ERROR) AND WAS SOLVED AFTER REMOVAL OF THE LOOSE REAMER HEAD FROM THE MEDULLARY CANAL AND SUBSEQUENT COMPLETION OF THE REAMING PROCESS. NO OTHER INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS WERE RECORDED. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN REAMER IRRIGATION ASSEMBLY DRIVE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593345 REAMER HTO SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1