BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL WIRE CUTTER 160MM

    MDR report key: 3824816 · Received May 21, 2014

    Report

    Report Number
    9680938-2014-10024
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    April 30, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS ADDITIONAL NARRATIVE: AN ADDITIONAL EVALUATION WAS PERFORMED. THE CUSTOMER REPORTED THE CUTTING BLADE BROKE OFF. THE REPAIR TECHNICIAN REPORTED THE WELD ON THE PIVOT SCREW FAILED, AND THE PLIERS STICK AND BIND. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT ON (B)(4) 2014. THE EVALUATION WAS CONFIRMED. 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: A MANUFACTURING EVALUATION WAS COMPLETED: THE CUTTING BLADE BROKE OFF AND IT BINDS UP SPORADICALLY WHILE OPENING AND CLOSING. THE MANUFACTURING EVALUATION SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ALL PARTS WERE NOT RETURNED TO PERFORM A FULL INVESTIGATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE WIRE CUTTER BLADE WAS BROKEN OFF. THE ISSUE WAS DISCOVERED BY THE TEAM THAT PERFORMS FUNCTIONALITY CHECKS, IT WAS REPORTED NO PATIENT WAS INVOLVED IN THE EVENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302415 SMALL WIRE CUTTER 160MM CUTTER, WIRE HXZ SYNTHES TUTTLINGEN T993676

    Patients

    Seq Age Sex Outcome Treatment
    1