BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLEAIRHOSE L3M F/SYST-SYNTHES

    MDR report key: 3171553 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03214
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    April 27, 2011
    Report Date
    May 13, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. INVESTIGATION COULD NOT CONFIRM THAT THE INNER HOSE WAS RUPTURED. THERE ARE INDICATIONS OF WEAR AND TEAR OCCURING DURING LONG TERM USE. AS THIS DEVICE IS 5 YEARS OLD, THE CAUSE WAS DETERMINED TO BE NORMAL WEAR AND TEAR DURING NORMAL USE. REVIEWING THE MANUFACTURING- AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: HOSE WAS BEING USED DURING PROCEDURE ON (B)(6) 2011 AND BECAME LOUD. WHILE REAMING WITH DRILL BIT, THE CONNECTION BLEW UP WHERE IT CONNECTED TO THE AIR DRIVE. THE REAMER WOULD NOT WORK SO IT WAS SET ASIDE. A MINUTE LATER, THE HOSE HAD BLOWN UP FOR A MOMENT AND THE SURGEON HEARD A LOUD NOISE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272577 DOUBLEAIRHOSE L3M F/SYST-SYNTHES HWE SYNTHES GMBH 31209

    Patients

    Seq Age Sex Outcome Treatment
    1