BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI II HANDPIECE

    MDR report key: 7042549 · Received November 17, 2017

    Report

    Report Number
    8030965-2017-50028
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Report Date
    October 23, 2017
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HWE
    UDI-DI
    07611819408357
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DATE RETURNED TO MANUFACTURER WAS DOCUMENTED AS NOV 10, 2017 ON THE INITIAL REPORT. IT HAS BEEN UPDATED AS NOV 9, 2017. PLEASE NOTE THAT THE MANUFACTURING NAME INFORMATION WAS INADVERTENTLY DOCUMENTED AS (B)(4) OF THE INITIAL MEDWATCH REPORT. THE CONTACT FACILITY NAME WAS INADVERTENTLY DOCUMENTED AS DEPUY SYNTHES POWER TOOLS OF THE INITIAL MEDWATCH REPORT. THIS INFORMATION HAS BEEN UPDATED TO DEPUY SYNTHES PRODUCTS LLC IN THIS MEDWATCH REPORT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTER'S PHONE NUMBER: (B)(6). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CONTROL UNIT OF THE SMALL BATTERY DRIVE DEVICE WAS NOT FUNCTIONING AND DEFECTIVE. IT WAS NOTED THAT THE CONTROLLER WAS DEAD AND THE MOTOR WAS WORN OUT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK OFF/OSCILLATION/ON SWITCH MODE FUNCTION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. 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
    820423 COLIBRI II HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES PRODUCTS LLC 07611819408357

    Patients

    Seq Age Sex Outcome Treatment
    1