BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD

    MDR report key: 3021520 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10482
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K033618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 MANUFACTURING EVALUATION SHOWED THAT THE COMPLAINT PART WAS RETURNED TO SUPPLIER FOR EVALUATION AND WAS FOUND THAT THE NOSE SECTION OF THE END CAP WAS DAMAGED. THE METAL COLOR LACKED OF ANODIZED COLOR. THE DETENT COULD NOT BE INSPECTED SINCE IT IS DAMAGED. THE PART SHOWS THAT IT WAS ENGAGED IN THE MATING PART. THE DAMAGE IS NOT CONSISTENT WITH MANUFACTURING OR INSPECTION PROCESSES. IT IS POTENTIALLY CONSISTENT WITH USAGE IN THE FIELD. THE OVERALL LENGTH AND THE THREAD LENGTH ARE FEATURES RELEVANT TO THE COMPLAINT CONDITION BUT CANNOT BE MEASURED ACCURATELY BECAUSE THE NOSE END OF THE TI END CAP IS DAMAGED. BALANCE OF THE FEATURES MEASURED CONFORMS TO SPECIFICATION. THE RETURNED PART IS TOO DAMAGED ON THE NOSE SECTION WE CONCLUDED THAT IT IS UNKNOWN IF MEETS SPECIFICATION. COMPLAINT PART CONFORMED TO SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE UNDAMAGED FEATURES (RELATED TO THE COMPLAINT) PASSED THE DIMENSIONAL INSPECTION PERFORMED BY SUPPLIER. BECAUSE OF THE CURRENT CONDITION OF THE PART, NO FURTHER DIMENSIONAL INVESTIGATION IS POSSIBLE. BASED ON THE EVALUATION OF THE RETURNED PRODUCT AND ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, IT IS CONCLUDED THAT THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. 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. UPDATED DATE OF EVENT ORIGINAL AWARENESS DATE IS (B)(4) 2012. ADDITIONAL INFORMATION WAS RECEIVED (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN RAFN PROCEDURE WITH SPIRAL BLADE, WHILE LOCKING THE SPIRAL BLADE WITH THE END CAP, THE 0MM EXTENSION END CAP WAS REPORTED TO BE TOO PROUD. THE SURGEON INSERTED THE DISTAL FEMORAL NAIL, AND THEN WENT TO INSERT THE HELICAL BLADE. SURGEON THEN INSERTED THE END CAP AND THE END CAP WAS SITTING PROUD APPROXIMATELY 1.5MM-2MM. SURGEON BACKED OUT THE END CAP AND THE HELICAL BLADE, SURGEON USED A DIFFERENT SCREW FOR THE NAIL. SURGEON DID NOT USE THE HELICAL BLADE; SURGEON WAS ABLE TO ACHIEVE A POINT OF FIXATION WITH THE SCREW. THE SPIRAL BLADE AND END CAP WERE EXPLANTED AND THE PROCEDURE WAS FINISHED WITH A LOCKING SCREW INSTEAD. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEMS. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    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
    123445 TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD HSB SYNTHES MONUMENT 4885301

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR