BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE CUTTER 220MM

    MDR report key: 4093882 · Received September 16, 2014

    Report

    Report Number
    2520274-2014-13643
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    March 14, 2014
    Manufacturer
    SYNTHES (USA)
    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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE AND REPAIR REPORTED THE FOLLOWING: THE CUSTOMER REPORTED THE CUTTING JAWS WERE BROKEN. THE REPAIR TECHNICIAN REPORTED THE INSERT FOR CUTTING JAWS BROKE OFF ON ONE SIDE. THE LEAF SPRING IS CRACKED AT THE SCREW AND THE ETCHING IS WORN OFF. THIS ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WAS SENT FOR FURTHER INVESTIGATION TO THE COMPLAINT HANDLING UNIT. FURTHER INVESTIGATION HAS BEEN LAUNCHED; INVESTIGATION RESULTS WILL BE REPORTED WHEN COMPLETED. 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. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE RETURNED WIRE CUTTER, 220MM WAS RECEIVED WITH A LARGE CHIP ON ONE SIDE OF THE CUTTING JAW, WHICH IS APPROXIMATELY 1.28 MM WIDE AND A SMALLER CHIP MEASURING 0.83MM ON THE SAME SIDE. THE WIRE CUTTER, 220MM (PART# 391.93, LOT# UNKNOWN) WAS RECEIVED FOR EVALUATION WITH COMPLAINT CATEGORY "BROKEN: INTRAOPERATIVELY" AND COMPLAINT DESCRIPTION ¿THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT THE CUTTING JAWS ARE BROKEN. DISCOVERED DURING A PROCEDURE.¿ TOP LEVEL PRODUCT DRAWING SE_388181 VERSION A WAS REVIEWED DURING THIS EVALUATION. DRAWING SE_388166 VERSION A FOR THE CUTTING EDGE COMPONENT "STELLIT PLATE" WAS ALSO REVIEWED. THE STELLIT PLATE IS MADE FROM STELLIT, A MATERIAL WHICH IS A RANGE OF COBALT-CHROMIUM ALLOYS DESIGNED FOR WEAR RESISTANCE. IT MAY ALSO CONTAIN TUNGSTEN OR MOLYBDENUM AND A SMALL AMOUNT OF CARBON. THIS WIRE CUTTER IS DESIGNED TO CUT WIRES UP TO Ø2.5MM. BASED ON A REVIEW OF THE RETURNED PRODUCT, THE MOST LIKELY CAUSE FOR THIS COMPLAINT IS USING THIS CUTTER TO CUT KIRSCHNER WIRES, CABLES OR SCHANZ PINS WHICH WERE LARGER THAN Ø2.5MM. IT IS ALSO POSSIBLE THE PRODUCT WAS USED TO CUT A PRODUCT IT SHOULD NOT HAVE CUT OR IT CHIPPED DUE TO NORMAL WEAR AND TEAR OVER TIME AS THE MANUFACTURING DATE OF PRODUCT IS UNKNOWN. IT IS UNCLEAR WHAT TRULY CAUSED THE CUTTER TO CHIP; THEREFORE, THE TRUE ROOT CAUSE IS INDETERMINATE. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE CUTTING JAWS WERE DISCOVERED BROKEN DURING A PROCEDURE. THE SURGEON HAD ANOTHER DEVICE ON HAND AND WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY DELAY OR HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571162 WIRE CUTTER 220MM CUTTER, WIRE HXZ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1