BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICK 3722066 1MM PT 90 DEG

    MDR report key: 2954802 · Received February 11, 2013

    Report

    Report Number
    9680837-2013-00002
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    JYT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED. THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THE TIP WAS BROKEN OFF AT THE EXTREME END OF THE INSTRUMENT. AT THIS POINT IN THE SHAFT, THE DIAMETER OF METAL IS VERY THIN SUCH THAT A 90 DEGREE BEND IN THE METAL CAN BE MADE BY THE SUPPLIER AND LEAVE A 1.0 MM PICK EXTENSION. THE STRESS ON THE METAL TO PRODUCE A 90 DEGREE BEND IS SIGNIFICANT ON THE 1.4021 SURGICAL STAINLESS STEEL MATERIAL. THIS UNIT WAS MANUFACTURED IN JUNE 2012, SO AGE OF THE INSTRUMENT IS NOT A FACTOR. THERE WERE NO OTHER UNITS FROM THIS MANUFACTURING LOT TO REVIEW. COMPARING THIS UNIT TO THE SAME INSTRUMENT IN LOT 201206MF2 SHOWED NO DIFFERENCES. ANALYSIS HAS CONCLUDED THAT THE MOST LIKELY ROOT CAUSE IS DUE TO EXCESSIVE FORCE BEING APPLIED TO THE END OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    IN A PREVIOUS MDR, AN EXPIRATION DATE WAS REPORTED. THIS DEVICE DOES NOT HAVE AN EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE PICK'S TIP BROKE OFF IN THE CHILD'S EAR. THE DOCTOR WAS PERFORMING A COCHLEAR IMPLANT ON THE CHILD AND SAW THAT THE TIP BROKE OFF. HE STATED THAT HE SAW THE SUCTION SUCK UP THE TIP OF THE PICK. THE DOCTOR IS FULLY CONFIDENT THAT THE TIP WAS SUCKED UP BY THE SUCTION, AND THE DOCTOR IS NOT GOING TO DO AN X-RAY. THERE WAS NO PATIENT IMPACT AND THERE WAS NO DELAY IN SURGERY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59714 PICK 3722066 1MM PT 90 DEG PICK, MICROSURGICAL EAR JYT MEDTRONIC, INC. 3722066 201206MF1

    Patients

    Seq Age Sex Outcome Treatment
    1 00002 YR