BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 80MM-STERILE

    MDR report key: 3033621 · Received April 3, 2013

    Report

    Report Number
    3003506883-2013-10091
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR ITS EMPLOYEES THAT THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE PART HAS MARKS IN THE ANODIZE COATING THAT ROTATE AROUND THE OD OVER THE LENGTH OF THE BODY OF THE BLADE THAT ARE CONSISTENT WITH IT HAVING BEEN ADVANCED THROUGH THE INSERTER. THERE ARE ALSO SCORE MARKS ON THE BASE OF THE FLUTE THAT IS IN LINE WITH THE ETCHING. THE OVERALL CONDITION IS GOOD AND THERE IS NO EVIDENCE OF ANY ANOMALOUS CONDITIONS. THIS COMPLAINT IS FOR THE LOCKING MECHANISM IN THE NAIL BEING IN THE LOCKED POSITION PRIOR TO INSERTION OF THE HELICAL BLADE WHICH WOULD PREVENT INSERTION. BASED ON THAT AND THE MEASUREMENTS MADE BY THE CHU ENGINEER, THERE IS NO EVIDENCE THAT THIS PART CONTRIBUTED TO THE COMPLAINT CONDITION. PART MET DESIGN INTENT, AND DID NOT CONTRIBUTE TO COMPLAINT CONDITION. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ISSUE WITH THE LOCKING MECHANISM IN THE NAIL. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HWC.

    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. ADDITIONAL INFORMATION: A MANUFACTURING EVALUATION WAS PERFORMED. AS RECEIVED, THE HELIX BLADE ANODIZE RUBBED AWAY ON THE SHAFT AND MAJOR DIAMETER, CONSISTENT WITH NORMAL USE. THE PRODUCT WAS INVESTIGATED TO THE LATEST DESIGN SPECIFICATIONS. SINCE ALL FEATURES RELEVANT TO THE COMPLAINT CONDITION MEET SPECIFICATION, THE COMPLAINT IS INVALID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN PROCEDURE, THE SURGEON PLACED THE NAIL AND ATTEMPTED TO IMPLANT THE HELICAL BLADE. THE BLADE WOULD NOT ADVANCE THROUGH THE HOLE. THE NAIL AND THE BLADE WERE REMOVED AND IT WAS NOTED THE LOCKING MECHANISM IN THE NAIL WAS ALREADY FULLY ADVANCED. THE SURGEON UNLOCKED THE NAIL AND PLACED IT BACK IN THE PATIENT. A NEW BLADE WAS USED BECAUSE THE OTHER HAD BEEN DAMAGED. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 15 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136222 11.0MM TI HELICAL BLADE 80MM-STERILE HSB SYNTHES ELMIRA 6654845

    Patients

    Seq Age Sex Outcome Treatment
    1