BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3000812 · Received March 12, 2013

    Report

    Report Number
    1719045-2013-10299
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. ORIGINAL AWARENESS DATE WAS (B)(4) 2011. DATE OF MOST RECENT INFORMATION WAS (B)(4) 2011. UPDATED CONCLUSION: REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE SUPPLIER¿S CERTIFICATIONS INDICATE THE CORRECT MATERIAL WAS USED AND CORRECT HARDNESS VALUES WERE OBTAINED. A MANUFACTURING EVALUATION WAS PERFORMED AND THE INSERTION HANDLE WAS RECEIVED WITH A DEEP DENT ON TOP OF THE DEVICE WITH SEVERAL SCRATCHES ALONG THE EDGES. THE TANG WAS DENTED ON THE TWO FLAT SIDES. A FUNCTIONAL CHECK WAS PERFORMED TO DETERMINE WHETHER THE CONSTRUCT WOULD PRESENT THE SAME PROBLEM THE SURGEON DESCRIBED AND IF THE PART MET THE MANUFACTURING REQUIREMENTS. TO ACCOMPLISH THIS, A BRAND NEW SET OF CONCOMMITENT PARTS WAS OBTAINED FROM STOCK. THE NEW CONSTRUCT PARTS, IN CONJUNCTION WITH THE RETURNED SUBJECT INSERTION HANDLE, ALIGNED THE BLADE THROUGH THE NAIL AS REQUIRED. THIS FUNCTIONAL TEST RECREATED THE SITUATION THAT THE SURGEON REPORTED. THE INTERCONNECTED CONSTRUCT USING THE RETURNED INSERTION HANDLE ASSEMBLED AS REQUIRED WITH THE BLADE SUCCESSFULLY ALIGNING WITH AND THROUGH THE NAIL. THEREFORE, THIS 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. 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. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE SUPPLIER'S CERTIFICATIONS INDICATE THE CORRECT MATERIAL WAS USED AND CORRECT HARDNESS VALUES WERE OBTAINED. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THE INSERTION HANDLE WITH A DEEP DENT ON TOP OF THE DEVICE AND SEVERAL SCRATCHES ALONG THE EDGES. THE TANG IS DENTED ON THE TWO FLAT SIDES. THIS COMPLAINT IS INDETERMINATE 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. 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. THIS DEVICE IS AN INSTRUMENT IS NOT IMPLANTABLE, THEREFORE THERE IS NO IMPLANT DATE.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 4 FOR FILE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN PROCEDURE THE SURGEON INSERTED GUIDE WIRE AND WAS IN THE PROCESS OF DRILLING HOLES FOR THE BLADE. THE SURGEON WAS HAVING PROBLEMS WITH THE DRILL STOP NOT HOLDING. THE SURGEON SELECTED ANOTHER DRILL STOP AND HAD TROUBLE WITH THE STOP NOT HOLDING, IT WOULD TRY TO ADVANCE WHILE DRILLING. THE SURGEON THEN TRIED TO INSERT THE BLADE WITH THE INSERTION HANDLE AND THE 130 DEGREE AIMING ARM WITH THE NAIL NOT GOING THROUGH THE NAIL. THE SURGEON HAD TO RE-POSITION THE CONSTRUCT AND THE NAIL WAS INSERTED. THE PROCEDURE WAS NOT DELAYED PAST FIFTEEN MINUTES.

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 4 FOR COMPLAINT FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103721 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS FZX SYNTHES MONUMENT 4544030

    Patients

    Seq Age Sex Outcome Treatment
    1