BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3082113 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10503
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 27, 2012
    Report Date
    March 27, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE DEVICE WAS RECEIVED, HOWEVER, NO EVALUATION IS AVAILABLE.

    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. THE PRODUCT EVALUATION AND VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMED THE EVENT DESCRIPTION AND REVEALED THAT THE FLANGE ON THE BUTTRESS COMPRESSION NUT THAT SNAPS INTO THE AIMING ARM IS DAMAGED. THE EDGE IS DEFORMED AND IS ROLLED UPWARD CREATING A BURR AROUND THE ENTIRE CIRCUMFERENCE. THE NUT WAS THREADED ONTO A BLADE GUIDE SLEEVE AND ASSEMBLED INTO THE AIMING ARM. THE NUT WAS DIFFICULT TO SNAP INTO PLACE BUT COULD EASILY BE INSERTED IF THE RELEASE BUTTON WAS PRESSED PRIOR TO INSERTION. ONCE ENGAGED, THE NUT HELD AS INTENDED EVEN WHEN IT WAS ROTATED 3 FULL REVOLUTIONS WHILE LIGHTLY PULLING BACK ON THE BLADE GUIDE SLEEVE. THE NUT RELEASED EASILY WHEN THE RELEASE BUTTON WAS DEPRESSED. THERE IS ALSO A RAISED BURR ON THE AIMING ARM RING THAT SNAPS INTO PLACE BEHIND THE FLANGE ON THE NUT. THERE IS A SCRAPE AROUND THE FULL CIRCUMFERENCE OF THE SMALL OD OF THE NUT FROM THAT BURR. THE DIFFICULTY INSERTING THE NUT INTO THE AIMING ARM IS DUE TO THE DAMAGE TO THE FLANGE BUT ONCE ENGAGED, IT RETAINS AND FUNCTIONS AS INTENDED. THE BUTTRESS COMPRESSION NUT WAS MANUFACTURED IN MAY 2003 AND THE AIMING ARM IN JANUARY 2004 SO THESE INSTRUMENTS HAVE BEEN USED WITHOUT ISSUE FOR OVER 8 YEARS. THE COMPLAINT CONDITION IS CAUSED BY DAMAGE TO THE FLANGE AREA OF THE NUT. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AND THE COMPLAINT CONDITION IS CONSIDERED TO BE DUE TO DAMAGE TO THE FLANGE AREA OF THE BUTTRESS NUT AND IS A RESULT OF THE CONDITION OF USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP NAILING PROCEDURE, THE COMPRESSION NUT KEPT COMING LOOSE FROM THE AIMING ARM. SURGEON WAS ABLE TO USE THE INSTRUMENTS TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183967 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS FZX SYNTHES BRANDYWINE 4698905

    Patients

    Seq Age Sex Outcome Treatment
    1