BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 3121514 · Received May 21, 2013

    Report

    Report Number
    8030965-2013-02295
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY (B)(4).  REPORT RECEIVED INDICATES THE OUR INVESTIGATION HAS SHOWN THAT THE COLIBRI DOES NOT FUNCTION ANYMORE AS COMPLAINED. THIS MACHINE WAS SENT BEFORE UNDER (B)(4) AND WE FOUND BACK THEN THAT THE MACHINE WAS NOT FUNCTIONAL BECAUSE OF A DAMAGED ELECTRONIC COMPONENT. THIS COMPONENT WAS REPLACED BACK THEN AND REGRETTABLY EXACTLY THIS COMPONENT WAS FOUND DAMAGED AGAIN, WHICH DID CAUSE THE REOCCURRENCE OF THIS MALFUNCTION. THIS ELECTRONIC COMPONENT IS COMPLETELY SEALED TO PROTECT IS AGAINST HUMIDITY AND OTHER EXTERNAL INFLUENCES. THIS SEAL MAKES IT IMPOSSIBLE TO ANALYZE THIS COMPONENT AND TO DEFINE THE CAUSE OF THIS OCCURRENCE AS THE INTERNAL ELECTRICAL CIRCUITS WOULD BE DESTROYED DURING OPENING THE SEAL. WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THIS 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 TPLO SURGERY, THE SURGEON USED THE LARGE OSCILLATING SAW ATTACHMENT WITH NO PROBLEMS. AFTERWARDS WHEN HE USED THE AO/ASIF QUICK COUPLING, IT WAS NOTED THAT THE POWER TOOL IS BLOCKED AND WAS NOT POSSIBLE TO START. THE DEVICE WAS RETURNED TO (B)(6) AFTER REPAIR AND REPORTEDLY THE DEVICE DID NOT WORK AGAIN. THE DEVICE WAS RETURNED AGAIN TO SERVICE AND REPAIR. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224634 COLIBRI HWE SYNTHES GMBH SER.NR. 11503

    Patients

    Seq Age Sex Outcome Treatment
    1