BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 4413039 · Received January 13, 2015

    Report

    Report Number
    3003787298-2015-10002
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Date of Event
    December 20, 2014
    Report Date
    December 20, 2014
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT INVESTIGATION EVALUATION: THE PERCUTANEOUS INSERTION HANDLE, HELICAL BLADE COUPLING SCREW, HELICAL BLADE, 11.0MM/3.2MM WIRE GUIDE, 130° AIMING ARM, BUTTRESS/COMPRESSION NUT, AND BLADE GUIDE SLEEVE ARE COMPONENTS OF THE TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM INTENDED FOR THE INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES. THE TECHNIQUE GUIDE WAS REVIEWED FOR PROPER USE OF THE INSTRUMENTATION FOR THIS SYSTEM. A COMPLAINT WAS REPORTED AGAINST ELEVEN PARTS, WHEREIN SEVEN OF THE PARTS WERE RETURNED: ONE PERCUTANEOUS INSERTION HANDLE (PART 357.418, LOT 1955160, MFG NOV2008), ONE HELICAL BLADE COUPLING SCREW (PART 357.377, LOT 6940192, MFG JUL2012), ONE HELICAL BLADE INSERTER (PART 357.372, LOT 7026618, MFG SEP2012), ONE 11.0MM/3.2MM WIRE GUIDE (PART 357.381, LOT 4991502, MFG MAY2005), ONE 130° AIMING ARM (PART 357.366, LOT 4781335, MFG JUL2004), ONE BUTTRESS/COMPRESSION NUT (PART 357.371, LOT 4801877, MFG AUG2004), AND ONE BLADE GUIDE SLEEVE (PART 357.369, LOT 4795449, MFG JUL2005). THE COMPLAINT REPORTED IS THAT ¿HELICAL BLADE WOULD NOT GO THROUGH THE INTRAMEDULLARY NAIL INTO THE FEMORAL HEAD DURING A PROCEDURE TO REPAIR A PROXIMAL FEMUR FRACTURE. THIS CAUSED A DELAY OF 15 MINUTES. THE NAIL HAD TO BE REINSERTED AFTER THE INSERTION HANDLE WAS EXCHANGED FOR ANOTHER DEVICE.¿ UPON RECEIPT OF THESE DEVICES, IT WAS SEEN THAT THE SYSTEM WAS ABLE TO BE ASSEMBLED PROPERLY; THE INSTRUMENTATION ALLOWS FOR SECURE CONNECTIONS, THE DEVICES CONFORM DIMENSIONALLY, AND THERE ARE NO SIGNS OF DAMAGE. THE DRAWINGS FOR THE HELICAL BLADE INSERTER WERE REVIEWED AND THE DESIGN, MATERIAL AND FINISHING PROCESSES ARE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. THIS COMPLAINT IS UNCONFIRMED GIVEN THAT THE RETURNED DEVICES WERE INTACT AND COULD BE PROPERLY ASSEMBLED. THE DESIGN OF THIS DEVICE IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. IT IS UNKNOWN WHAT LED TO THIS COMPLAINT CONDITION; HOWEVER IT IS MOST PROBABLE THAT THE SYSTEM WAS NOT PROPERLY ASSEMBLED CAUSING A MISALIGNMENT IN THE INITIAL HELICAL BLADE TRAJECTORY. 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.

    Additional Manufacturer Narrative · 1

    PATIENT¿S EXACT WEIGHT WAS REPORTED AS (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE WAS RECEIVED BY MANUFACTURER ON DECEMBER 30, 2014. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW: MANUFACTURE DATE: SEPTEMBER 7, 2012. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND REWORK WAS FOUND ON P/N 357.372, LOT 7026618 FOR BLACK RESIDUE IN THE INSIDE DIAMETER OF THE GUIDE SHAFT. THE PARTS WERE CLEANED, INSPECTED, AND PASSED. THIS REWORK IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE THE ISSUE IS VISUAL. NON-CONFORMANCE REPORT (B)(4) WAS FOUND ON P/N 357.372.2, LOT 6948263 FOR SPOTS IN ANODIZE FINISH. THE PARTS WERE REWORKED INSPECTED AND PASSED. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE THE ISSUE IS VISUAL. NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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 A HELICAL BLADE WOULD NOT GO THROUGH THE INTRAMEDULLARY NAIL INTO THE FEMORAL HEAD DURING A PROCEDURE TO REPAIR A PROXIMAL FEMUR FRACTURE. THE NAIL HAD TO BE REINSERTED AFTER THE INSERTION HANDLE WAS EXCHANGED FOR ANOTHER DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. A SURGICAL DELAY OF 15 MINUTES WAS REPORTED. THIS REPORT IS 2 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28018 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH SYNTHES JENNERSVILLE 7026618

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR