BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS INSERTION HANDLE

    MDR report key: 3010017 · Received March 18, 2013

    Report

    Report Number
    1719045-2013-10369
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    November 2, 2011
    Report Date
    November 2, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PRODUCT DEVELOPMENT EVALUATION REVEALED THE 12.0MM/8.0MM PROTECTION SLEEVE WAS STUCK THROUGH THE SUBMITTED LFN INSERTION HANDLE. A ROLLED OVER EDGE OF THE OBLIQUE 120 DEGREE HOLE IS PROVIDING RESISTANCE FOR THE SLEEVES. THIS EDGE IS DUE TO HAMMER BLOWS TO THE INFERIOR SIDE OF THE LFN INSERTION HANDLE. HITTING OF THE INSERTION HANDLE DIRECTLY IS NOT PART OF THE TECHNIQUE. IMPROPER TECHNIQUE, VARIATIONS IN PATIENT ANATOMY, ETC. MAY LEAD TO POOR OUTCOMES OF THE LFN SYSTEM. BASED ON THE CONDITION OF THE RETURNED DEVICE AND EVALUATION, THE COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FEMORAL NAIL PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTY GETTING THE TROCAR TO GO THROUGH THE INSERTION HANDLE AND A MALLET WAS USED TO GET IT THROUGH. AFTER THE PROCEDURE, THE TWO PIECES COULD NOT BE SEPARATED AND REMAINED STUCK TOGETHER. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113025 PERCUTANEOUS INSERTION HANDLE LXH SYNTHES MONUMENT 1828307

    Patients

    Seq Age Sex Outcome Treatment
    1