BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX

    MDR report key: 5247559 · Received November 24, 2015

    Report

    Report Number
    3003875359-2015-10503
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Report Date
    October 14, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 18 JUNE 2008. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED INSTRUMENT (03.008.011, LOT 1900432 MANUFACTURE JUNE 2008) WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED AS THE INSERTER TOP IS NO LONGER RETAINED BY THE SPIRAL BLADE INSERTER BODY. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES LEADING TO THE FAILURE ARE UNKNOWN; DUE TO THE WITNESS MARKS ON THE TOP OF THE INSERTER TOP, IT IS LIKELY THAT ARRANT HAMMER BLOWS CONTRIBUTED TO THE COMPLAINT CONDITION. PER THE TECHNIQUE GUIDE, THE SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX IS A COMPONENT OF THE HINDFOOT ARTHRODESIS NAIL-EX INSTRUMENT SET (01.008.003) WHICH IS UTILIZED TO FACILITATE TIBIOTALOCALCANEAL ARTHRODESIS. THE INSERTER IS SPECIFICALLY UTILIZED TO INSERT A SPIRAL BLADE FOR DISTAL LOCKING OF HINDFOOT ARTHRODESIS NAILS. THE SPIRAL BLADE IS ATTACHED TO THE INSERTER USING A CONNECTING SCREW AND THE ASSEMBLY IS PASSED OVER A GUIDE WIRE AND THROUGH THE AIMING ARM ADAPTER. ONCE IN PLACE THE BLADE CAN BE ADVANCED INTO THE BONE USING ¿LIGHT CONTROLLED BLOWS¿ OF A HAMMER. AFTER DISASSEMBLY IT WAS FOUND THAT A PORTION OF THE INSERTER TOP PLUNGER WAS BROKEN OFF (APPROXIMATELY 10MMX20MM), INHIBITING THE TOP FROM FULLY ENGAGING WITH THE INSERTER BODY. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES LEADING TO THE FAILURE ARE UNKNOWN; DUE TO THE WITNESS MARKS ON THE TOP OF THE INSERTER TOP, IT IS LIKELY THAT ARRANT HAMMER BLOWS CONTRIBUTED TO THE COMPLAINT CONDITION. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBERS AND IN EACH INSTANCE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOTS NUMBERS WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 THAT UPON INSPECTION AT THE METRO OFFICE, POST DECONTAMINATION, THE TOP OF THE SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX NO LONGER HOLDS THE HANDLE. THE LAST CASE THIS DEVICE WAS USED, IT FUNCTIONED AS EXPECTED. THIS DID NOT OCCUR INTRA-OPERATIVELY; THERE WAS NO PATIENT INVOLVEMENT. WHEN THE DEVICE WAS RECEIVED BY THE MANUFACTURER IT WAS NOTED, A PORTION OF THE LOCKING MECHANISM WAS BROKEN OFF AND NOT RETURNED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778552 SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX GUIDE FZX SYNTHES HAGENDORF 1900432

    Patients

    Seq Age Sex Outcome Treatment
    1