BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER

    MDR report key: 4485314 · Received February 4, 2015

    Report

    Report Number
    2520274-2015-10790
    Event Type
    Malfunction
    Date Received
    February 4, 2015
    Date of Event
    January 21, 2015
    Report Date
    January 21, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS NOT PROVIDED. THIS REPORT IS FOR AN UNKNOWN 14.5 REAMER HEAD. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PLANNED REVISION SURGERY TO TREAT A NON-UNION INVOLVING THE EXCHANGE NAILING OF A LATERAL FEMORAL NAIL (LFN) TO BLADE PLATE WITH REAMER/IRRIGATOR/ASPIRATOR (RIA) USED TO COLLECT A GRAFT, THE LFN WAS REMOVED SUCCESSFULLY BUT IT WAS REPORTED THAT THE RIA WAS DIFFICULT TO ASSEMBLE. A PROBLEM WAS ENCOUNTERED WITH GETTING THE INNER REAMING MECHANISM TO COUPLE WITH THE OUTER DISPOSABLE ASPECT. EVENTUALLY THE SYSTEM WAS COUPLED AND THE REAMER HEAD WAS CHECKED TO SEE IT ROTATED FREELY AND THAT WATER FLOWED FROM THE END. ON THE FIRST PASS THE 14.5 REAMER HEAD CAME OFF. THE COUPLING PRONGS HAD SNAPPED AND AS A RESULT THE INNER SLEEVE COULD NOT DISENGAGE FROM THE OUTER DISPOSABLE TUBE. A SHORTER, 340 REAMING ROD WAS THEN USED IN CONJUNCTION WITH A 13.5 REAMER HEAD. A 14.5 REAMING HEAD WAS THEN REQUESTED ALTHOUGH IT WAS INDICATED THAT THE SYSTEM WAS ONLY DESIGNED FOR A SINGLE PASS. TWO ADDITIONAL PASSES WERE PERFORMED WITH THE 14.5 REAMER HEAD. HAVING PLANNED TO REPLACE THE LFN WITH A BLADE PLATE, SOME ANESTHETIC PROBLEMS REQUIRED THAT A CHANGE TO A NAIL. THE LARGEST DIAMETER NAIL WAS REQUESTED. SINCE ONLY A 12MM DIAMETER LFN WAS AVAILABLE, A 14MM PROXIMAL FEMORAL NAIL ¿ ANTIROTATION (PFNA) WAS AVAILABLE AND WAS INSERTED. AFTER THE OPERATION IT WAS NOTED THAT THE INNER REAMING ROD (314.743) HAD LOST A SECTION OF ITS DISTAL TIP. THIS COULD HAVE HAPPENED PRIOR TO THE OPERATION. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. THE PATIENT WAS IN CRITICAL CONDITION AFTER THE PROCEDURE AND IS IN INTENSIVE CARE UNIT AS A RESULT OF SURGICAL COMPLICATIONS CAUSED BY NUMEROUS FACTORS. THIS COMPLAINT ADDRESSES THE REAMER HEAD, REAMING ROD AND RIA DRIVE SHAFT. THIS REPORT IS FOR AN UNKNOWN 14.5 REAMER HEAD. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80666 REAMER HTO SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1