BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL WIRE CUTTER 160MM

    MDR report key: 4151379 · Received October 8, 2014

    Report

    Report Number
    2520274-2014-13975
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HXZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE TIP OF THE SUPERIOR CUTTER BLADES IS MISSING A SEGMENT OF MATERIAL, THE BALANCE OF THE DEVICE IS INTACT. THE SMALL WIRE CUTTER, 160 MM LENGTH IS FOR USE WITH KIRSCHNER WIRES UP TO 1.5MM DIAMETER. ONE PAIR OF SMALL WIRE CUTTERS, 160MM LENGTH (PART# 391.90, LOT# 9105, MFG DATE UNKNOWN) WAS RETURNED WITH THE COMPLAINT THAT ¿A SMALL WIRE CUTTER, PART NUMBER 391.90, THAT WAS BEING USED TO REMOVE SOME GUIDE WIRES DURING AN ORTHOPEDIC PROCEDURE (REPAIRING A FRACTURED FEMUR) AND THE TIP OF THE CUTTERS BROKE OFF.¿ UPON RECEIPT OF THE DEVICE IT WAS SEEN THAT THIS COMPLAINT IS CONFIRMED AS THE TIP OF THE SUPERIOR CUTTER BLADES IS MISSING A SEGMENT OF MATERIAL, THE BALANCE OF THE DEVICE IS INTACT. THE DRAWINGS FOR THIS DEVICE WERE REVIEWED, (391_90 REVS A-F). GIVEN THE DIMENSIONS OF THIS DEVICE, IT WAS MANUFACTURED TO 391_90 REV A. THIS DEVICE WAS MANUFACTURED PRIOR TO JULY 2002, THE DIMENSIONS HAVE BEEN CHANGED FOLLOWING THE RELEASE OF THIS LOT TO MORE ROBUST SPECIFICATIONS. IT IS NOT KNOWN WHAT CAUSED THIS DEVICE FAILURE, THIS COULD HAVE BEEN CAUSED BY CUTTING WIRES GREATER THAN 1.5MM IN DIAMETER, CUTTING MATERIAL OUTSIDE OF THE SPECIFIED RANGE, OR GIVEN THE AGE OF THIS DEVICE, REGULAR USE OVER TIME. THIS COMPLAINT IS CONFIRMED, HOWEVER THE DESIGN OF THIS DEVICE WAS FOUND TO BE ADEQUATE FOR ITS INTENDED USE. 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 USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. THE LOT NUMBER PROVIDED COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: LOT 9105: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE TIP OF THE CUTTERS BROKE OFF. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. 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 A SMALL WIRE CUTTER WAS BEING USED TO REMOVE SOME GUIDE WIRES DURING AN ORTHOPEDIC PROCEDURE OF REPAIRING A FRACTURED FEMUR AND THE TIP OF THE CUTTERS BROKE OFF. THE TIP WAS NOT RETAINED IN THE PATIENT. THERE WAS ANOTHER DEVICE ON HAND AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THIS IS A VETERINARY CASE AND THERE IS NO HUMAN PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632909 SMALL WIRE CUTTER 160MM CUTTER,WIRE HXZ SYNTHES USA 9105

    Patients

    Seq Age Sex Outcome Treatment
    1