BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLEAIRHOSE F/MINI AIR DRILL NO. 512.1

    MDR report key: 3171559 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03083
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    March 31, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. THE DEVICE HISTORY RECORD REPORTS THE COMPLAINT TO BE INDETERMINATE, THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    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. A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. THE INVESTIGATION OF THE DEVICE FOUND THAT THE MACHINE COUPLING IS LEAKING. A BIT OF THE USED TEFLON TAPE TO WRAP THE THREAD BECAME PINCHED BETWEEN THE SEAL AND THE COUPLING BODY. THIS CONDITION WAS NOT DETECTED DURING THE FINAL CONTROL. AS WE ARE NOT AWARE OF ANY OTHER SIMILAR COMPLAINTS RELATED TO THIS ARTICLE AND LOT NUMBER WE CONSIDER THIS COMPLAINT TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DOUBLE AIR HOSE WAS RECEIVED ON AN UNKNOWN DATE IN (B)(6) 2011, USED ONE OR TWO TIMES, AND THEN ON AN UNKNOWN DATE IT WAS FOUND THAT IT LEAKS GAS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272579 DOUBLEAIRHOSE F/MINI AIR DRILL NO. 512.1 HSZ SYNTHES GMBH 13368

    Patients

    Seq Age Sex Outcome Treatment
    1