BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 2993852 · Received March 8, 2013

    Report

    Report Number
    8030965-2013-00801
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    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. DEVICE WAS USED IN A VETERINARY PROCEDURE. DEVICE WAS USED AS A VETERINARY PRODUCT. DEVICE IS MARKETED FOR HUMAN USE. HEALTH PROFESSIONAL IS VETERINARY PERSONNEL. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. OUR INVESTIGATION HAS SHOWN THAT THE COLIBRI DOES NOT FUNCTION ANYMORE. THIS FAULT WAS CAUSED BY A DAMAGED ELECTRONIC COMPONENT IN THE HOUSING. AFTER THIS COMPONENT WAS CHANGED THE DEVICE WAS FUNCTIONAL AS REQUIRED AGAIN. BASED ON THE RECEIVED INFORMATION WE ARE NOT ABLE TO DETERMINE THE OCCURRENCE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A VETERINARY SURGERY, IT WAS REPORTED THE DEVICE (SMALL BATTERY DRIVE 532.001) WAS BLOCKING SUDDENLY. REPORTEDLY THE BLOCKING HAPPENS WITH THE ATTACHMENT OF THE AO/ASIF QUICK COUPLING (05.001.250) AND ESPECIALLY WITH THE OSCILLATING SAW ATTACHMENT 532.021. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100057 COLIBRI HWE SYNTHES GMBH SER.-NR. 11503

    Patients

    Seq Age Sex Outcome Treatment
    1