BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX

    MDR report key: 3080825 · Received April 26, 2013

    Report

    Report Number
    8030965-2013-11114
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    July 19, 2012
    Report Date
    July 19, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 EVENT EVALUATION REVEALED THAT THE INTERFACE BETWEEN THE HUMERAL NAIL EX AND THE INSERTION HANDLE (PART 03.010.054) WAS DESIGNED SO THAT THE NAIL WILL MOUNT IN ONLY ONE ORIENTATION. THE DIMENSIONS OF THE PROXIMAL END OF THE NAIL AND THE INSERTION HANDLE HAVE BEEN APPROPRIATELY SIZED TO ENSURE THAT THIS WILL NOT HAPPEN. THERE IS AN EXTREMELY SLIGHT POSSIBILITY THAT THE OR STAFF COULD HAVE DEFORMED THE PROXIMAL END OF THE NAIL WHILE ATTACHING THE INSERTION HANDLE. IT CANNOT BE CONFIRMED IF THIS HAPPENED SINCE THE NAIL WAS NOT RETURNED. THE RISK ANALYSIS ((B)(4)) FOR THE EX HUMERAL NAIL WAS REVIEWED AND A RISK RELATING TO MIS-MOUNTING THE INSERTION HANDLE HAS BEEN CAPTURED. THE SEVERITY OF HARM THAT WAS ASSIGNED FOR THIS RISK IS 3 CORRESPONDING TO AN INCREASE IN PROCEDURE TIME OF GREATER THAN 20 PERCENT. ACCORDING TO THE COMPLAINT, THE REPORTED EVENT CAUSED A 45 MINUTE INCREASE IN SURGERY TIME WITHOUT HARM TO THE PATIENT. THIS WOULD INDICATE THAT THE ASSIGNED SEVERITY OF HARM IS ACCURATE. THE RATE OF OCCURRENCE IS DEFINED AS A 1 INDICATING LESS THAN 1:10,000. A REVIEW OF THE COMPLAINT DATABASE INDICATED THAT THIS IS THE ONLY COMPLAINT OF ITS KIND IN THE LAST 5 YEARS. DURING THIS TIME SYNTHES HAS SOLD MORE THAN 20,000 NAILS. BASED ON THIS DATA IT CAN BE CONCLUDED THAT THE ASSIGNED RATE OF OCCURRENCE IS ACCURATE. A REVIEW OF THE PRODUCT DESIGN INDICATES THAT THE NAIL AND INSERTION HANDLE WERE PROPERLY DESIGNED IN ORDER TO AVOID MOUNTING THE INSERTION HANDLE INCORRECTLY. PRODUCT DEVELOPMENT ATTEMPTED TO REPLICATE THE COMPLAINT WITH THE RETURNED INSERTION HANDLE AND WAS UNABLE TO DO SO. IT APPEARS THAT THE ONLY POSSIBLE WAY THAT THIS COULD OCCUR WOULD BE IF THE PROXIMAL NAIL INTERFACE WERE DEFORMED. IT IS NOT POSSIBLE TO DETERMINE WHETHER THIS HAPPENED SINCE THE NAIL WAS NOT RETURNED AND THE COMPLAINT DID NOT DESCRIBE THE CONDITION OF THE NAIL. THE RISK ASSOCIATED WITH MIS-MOUNTING THE INSERTION HANDLE WAS IDENTIFIED WITH AND APPROPRIATE LEVEL OF SEVERITY AND RATE OF OCCURRENCE IN THE DESIGN CLINICAL RISK MANAGEMENT. FROM A DESIGN STANDPOINT THE COMPLAINT IS INVALID. THE MANUFACTURING EVALUATION SHOWED THAT THERE ARE NO VISIBLE WEAR OR DAMAGES. THE AIMING ARM PASSED THE REQUIRED FUNCTIONAL TEST AS PER (B)(4) AD SUCCESSFULLY. THE PROBLEM AS PER EVENT DESCRIPTION COULD NOT BE DUPLICATED. THE DEVICE MEETS FULLY TO THE SPECIFICATIONS. SEE ATTACHED INVESTIGATION AND MEASURING PROTOCOLS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HUMERAL NAIL PROCEDURE, THE HANDLE AND ARM WERE ATTACHED; HOWEVER, THE WAY THEY WERE ATTACHED CAUSED THE SURGEON TO MISS THE GUIDE PIN/WIRE. THE SURGEON REMOVED THE PIN AND CHANGED THE WAY HE ATTACHED THE PARTS SO THAT THEY WOULD LINED UP CORRECTLY. HE WAS THEN ABLE TO COMPLETE SURGERY WITHOUT FURTHER INCIDENT. APPROXIMATELY 45 MINUTES WERE ADDED TO THE SURGERY TIME DUE TO THIS PROBLEM; HOWEVER NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182995 SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX LXH SYNTHES GMBH 3777719

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention