BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA REAMER HEAD Ø15

    MDR report key: 3190716 · Received June 26, 2013

    Report

    Report Number
    1719045-2013-01725
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 27, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    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. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL EVALUATION WAS CONDUCTED BY SYNTHES (B)(4) AND THE REPORT INDICATES: THE COMPLAINED RIA TUBE ASSEMBLY WAS FORWARDED TO THE RESPONSIBLE PRODUCT DEVELOPMENT MANAGER AND WAS CHECKED FOR CONFORMANCE TO SPECIFICATIONS. BASED ON THE FINDINGS THAT THE REAMER IS STIFF, IT WAS DISMANTLED AND THE REAMER WAS VISUALLY INSPECTED. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF WRONG ASSEMBLING OF THE REAMER AND FLEXIBLE SHAFT. NO MANUFACTURING RELATED ISSUES WERE FOUND. IT WAS ALSO DETERMINED; THE ARTICLES WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS. FURTHER, THE DEVICE HISTORY RECORDS (DHR) REVIEW COULD NOT BE PERFORMED AS IT IS NOT AVAILABLE FOR THIS LOT. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2013, THE PROPELLER SHAFT BLOCKED THE REAMER. THE SURGEON STATED THAT A 520MM REAMER/IRRIGATOR/ ASPIRATOR (RIA) HOSE SYSTEM WAS USED, WHICH CAME TO THE OPERATING TABLE WITH A 15MM REAMER. WHEN THE PROPELLER SHAFT OF THE HOSE SYSTEM WAS INSTALLED, IT BLOCKED THE REAMER AND PREVENTED IT FROM ROTATING FREELY, WITH AN UNUSUAL NOISE BEING HEARD. IT WAS ALSO REPORTED; THE SURGEON STATED THAT HE ABSTAINED FROM USING THE SYSTEM THIS WAY FOR FEAR OF ITS BECOMING BLOCKED INSIDE THE PATIENT. THE SURGEON REVIEWED THE SYSTEM SEVERAL TIMES, DISASSEMBLING IT AND REVIEWING THE PARTS WITH NOTHING ABNORMAL BEING OBSERVED AT FIRST SIGHT. THE REAMER ASSEMBLY WAS REVIEWED AND FOUND CORRECT. ALL THE PARTS WERE ASSEMBLED AGAIN BUT THE PROBLEM PERSISTED. THE SPECIALIST REFUSED TO USE THE SYSTEM THIS WAY AND AUTHORIZED ANOTHER HOSE SYSTEM, THIS TIME THE 360MM ONE, AND A NEW 15 MM REAMER, BECAUSE THE OLD ONE WAS DAMAGED WHEN TRIED TO REMOVE IT. THE WHOLE SYSTEM WAS ASSEMBLED AGAIN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 3 OF 3 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 3 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291193 RIA REAMER HEAD Ø15 HTO SYNTHES MONUMENT 8234765

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR