BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 2972503 · Received February 21, 2013

    Report

    Report Number
    2530088-2013-10121
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    December 29, 2011
    Report Date
    December 29, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. AS RECEIVED, THE INSERTION HANDLE WAS RETURNED WITH MARKS/SCRATCHES ON THE SURFACE FINISH. THE HANDLE, AND THE GROOVED LOCATION USED FOR SLIDING THE CAP, WERE WORN. BOTH PRESENTED SOME DAMAGE ALONG THE TOPS, EDGES , GROOVES AND ON TOP OF THE INSERTION HANDLE. THE DIMENSIONS MEASURED WERE WITHIN SPECIFICATION. HOWEVER, NOT ALL RELEVANT FEATURES COULD BE CHECKED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED FROM A MANUFACTURING STANDPOINT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: 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. ORIGINAL AWARENESS DATE IS (B)(6) 2011 ORIGINAL DATA SUBMITTED WAS INCOMPLETE: A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. AS RECEIVED, THE INSERTION HANDLE WAS RETURNED WITH MARKS/SCRATCHES ON THE SURFACE FINISH. THE HANDLE, AND THE GROOVED LOCATION USED FOR SLIDING THE CAP, WERE WORN. BOTH PRESENTED SOME DAMAGE ALONG THE TOPS, EDGES , GROOVES AND ON TOP OF THE INSERTION HANDLE. THE DIMENSIONS MEASURED WERE WITHIN SPECIFICATION. HOWEVER, NOT ALL RELEVANT FEATURES COULD BE CHECKED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, THE SURGEON WAS ATTEMPTING TO PLACE A 5.0MM LOCKING SCREW DISTALLY AND THE SCREW MISSED THE NAIL. THE SURGEON REMOVED THE LOCKING SCREW AND THE INSTRUMENTS, AND PLACED THE SCREW FREE-HAND, ADDING APPROXIMATELY 30 MINUTES TO THE PROCEDURE TIME. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76408 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS FZX SYNTHES BRANDYWINE 4981321

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention