BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX

    MDR report key: 3191436 · Received June 26, 2013

    Report

    Report Number
    2530088-2013-00984
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 28, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. AGE SHOULD BE (B)(6).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE PRODUCT DEVELOPMENT EVENT EVALUATION REPORTS FROM A DESIGN EVALUATION THAT THE VISUAL INSPECTION OF THE TWO RETURNED PARTS SHOWED THAT THE TANGS ON THE WORKING END OF THE SPIRAL BLADE INSERTER 358.696 WERE BENT OUTWARD. IT IS NOT CLEAR FROM THE INFORMATION SUPPLIED IN THE COMPLAINT WHAT CAUSED THE TANGS TO BEND. IT IS POSSIBLE THAT THEY WERE BENT PRIOR TO THE SURGERY WHERE THE EVENT TOOK PLACE. BECAUSE THE TANGS WERE BENT OUTWARDS, IT EFFECTIVELY INCREASED THE OUTER DIAMETER OF THE SPIRAL BLADE INSERTER. THIS IS ULTIMATELY WHAT CAUSED THE SHAFT OF THE INSTRUMENT NOT TO PASS THROUGH THE HOLE IN THE AIMING ARM. A REVIEW OF THE RISK ANALYSIS ASSOCIATED WITH THIS PART SHOWED THAT THIS RISK WAS CAPTURED WITH A SEVERITY OF HARM OF 3 AND A RATE OF (B)(4). AS DESCRIBED IN THIS COMPLAINT THE RESULT OF THE DESCRIBED EVENT WAS AN INCREASE IN SURGERY TIME OF 15-20 MINUTES. THIS IS CONSISTENT WITH THE SEVERITY LEVEL OF 3 AS DEFINED IN THE MOST RECENT VERSION OF THE RISK ANALYSIS. (B)(4). A REVIEW OF THE PRODUCT DRAWINGS SHOWS THAT THE PARTS ARE APPROPRIATELY DIMENSIONED SUCH THAT THE INSERTER SHOULD FIT EVERY TIME. IN CONCLUSION A REVIEW OF THE DRAWINGS INDICATES THAT DIMENSIONALLY THE INSERTER WILL FIT THROUGH THE AIMING ARM AS INTENDED UNDER ALL DIMENSIONAL CIRCUMSTANCES. THE RISK ANALYSIS FOR THE INSERTER WAS REVIEWED AND THIS EVENT WAS ADEQUATELY CAPTURED. IT IS CLEAR BY LOOKING AT THE WORKING END OF THE INSERTER THAT THE TANGS WERE BENT OUTWARD EFFECTIVELY INCREASING THE OUTER DIAMETER OF THE INSERTER. THIS IS WHAT ULTIMATELY CAUSED THE INSERTER NOT TO FIT IN THE AIMING ARM. IT IS NOT AT ALL CLEAR WHAT CAUSED THE TANGS TO BEND AND IT IS POSSIBLE THAT THEY WERE BENT PRIOR TO THE SURGICAL PROCEDURE. OVERALL, THERE IS NO EVIDENCE TO SUGGEST THAT THE DESIGN OF THIS PRODUCT CONTRIBUTED TO THIS COMPLAINT; THEREFORE, IT¿S DISPOSITION IS DEEMED INVALID FROM A DESIGN STANDPOINT. THE MANUFACTURING EVALUATION REPORTS AS RECEIVED CONDITION TO BE THAT THE DEVICE'S GUIDING BORE FOR THE SPIRAL BLADE INSERTER VISIBLY WAS DAMAGED DURING FORCIBLE ATTEMPTS TO INSERTION A DAMAGED SPIRAL BLADE INSERTER. THERE ARE VISIBLE MARKS AT THE RUN-IN ON BOTH SIDES OF THE GUIDING BORE. IN CONCLUSION THE DEVICE IN QUESTION WAS MANUFACTURED IN (B)(4) IN JANUARY 2007. THE COMPLAINT MANUFACTURING EVALUATION CLEARLY STATES THAT THE INSERTER WAS THE CAUSATIVE INSTRUMENT BECAUSE IT WAS DAMAGED; THE SPREAD CONDITION OF THE TANGS PREVENT THE INSTRUMENT FROM FUNCTIONING AS INTENDED. THE SPIRAL BLADE AIMING ARM PASSED THE REQUIRED FUNCTIONAL TEST WITH A REFERENCE INSERTER SUCCESSFULLY. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 8-HOLE LCP PLATE AND SCREWS ON (B)(6) 2013 FOR HUMERAL FRACTURE FROM A FALL ON AN UNKNOWN DATE. APPROXIMATELY 2-1/2 TO 3 WEEKS POST-OP, THE PATIENT FELL AGAIN, AND REFRACTURED THE SAME HUMERUS ADJACENT TO THE PREVIOUS PLATE AND SCREW FIXATION. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013. THE SURGEON REMOVED THE PLATE AND SCREWS WHICH WERE INTACT, AND IMPLANTED A HUMERAL NAIL-EX WITH SPIRAL BLADE. DURING THE REVISION SURGERY, THE AIMING ARM AND THE INSERTION HANDLE FOR THE SPIRAL BLADE WOULD NOT FIT TOGETHER PROPERLY. SURGEON PROCEEDED BY INSERTING THE SPIRAL BLADE BY HAND, WITHOUT USING THE INSERTION HANDLE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER PROBLEM. THERE WAS A 15-20 MINUTE DELAY TO THE PROCEDURE. THIS IS 1 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291456 SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX LXH SYNTHES BRANDYWINE 5408501

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR