BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI II HANDPIECE

    MDR report key: 18357650 · Received December 19, 2023

    Report

    Report Number
    8030965-2023-15889
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 5, 2023
    Report Date
    December 19, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EVALUATED AND IT WAS DETERMINED THAT THE REPORTED CONDITION WAS NOT CONFIRMED. THEREFORE, THE ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, DURING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD INTERMITTENT OPERATION, WOULD NOT REVERSE AND HAD UNINTENDED ACTIVATION. THE DEVICE ALSO FAILED PRETESTS FOR CHECK FOR UNINTENDED MOTION, CHECK THE FORWARED (FWD) / REVERSE (REV) MODES FUNCTION AND CHECK SWITCHING FUNCTION FWD / REV IN RUNNING MODE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED FROM SINGAPORE THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE WOULD NOT REVERSE AND HAD UNINTENDED MOTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR CHECK FOR UNINTENDED MOTION, CHECK THE FORWARD (FWD) / REVERSE (REV) MODES FUNCTION AND CHECK SWITCHING FUNCTION FWD / REV IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT FUNCTION REGULARLY WITH ACCESSORIES PRIOR TO SURGERY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139293 COLIBRI II HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown