BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL WIRE CUTTER 160MM

    MDR report key: 4452071 · Received January 26, 2015

    Report

    Report Number
    9680938-2015-10014
    Event Type
    Malfunction
    Date Received
    January 26, 2015
    Report Date
    January 13, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SERVICE HISTORY REVIEW: LOT A7NA20/4802265 - NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JULY 15, 2004. THIS EVENT REPRESENTS A VETERINARY CASE ¿ NO PATIENT DATA WILL BE REPORTED. DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EMPLOYEE AT THE VETERINARY CLINIC REPORTED THAT BOTH SMALL WIRE CUTTER 160MMS WERE DISCOVERED TO BE CHIPPED BEFORE SURGERY TOOK PLACE ON A DOG. THERE WAS NO SURGICAL DELAY. OTHER INSTRUMENTS WERE USED FOR THE SURGERY. NO NEGATIVE IMPACT TO THE ANIMAL. THIS IS A VETERINARY CASE. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60304 SMALL WIRE CUTTER 160MM CUTTER, WIRE HXZ SYNTHES TUTTLINGEN 4802265

    Patients

    Seq Age Sex Outcome Treatment
    1