BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 6449382 · Received March 31, 2017

    Report

    Report Number
    1719045-2017-10272
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    March 8, 2017
    Report Date
    March 8, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE IS HWC. OTHER NUMBER¿UDI: (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: (B)(4). DATE OF MANUFACTURE: JAN 3, 2017. EXPIRATION DATE: NOV 30, 2028. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    UPDATED DEVICE HISTORY RECORD REVIEW: PART 456.318S, SYNTHES LOT H260892: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JANUARY 03, 2017. EXPIRATION DATE: NOVEMBER 30, 2028. COMPONENT PARTS REVIEWED: PART 456.314.3 (LOCK DRIVER TFN, BP-55) LOT: H091645, PART 456.315.2 (130 DEGREE LOCK PRONG TFN BP-58), LOT: H217208, 21069 (RAW MATERIAL LOT BP-80), LOT 9876154. INSPECTION SHEET MET INSPECTION ACCEPTANCE CRITERIA. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. A PRODUCT INVESTIGATION WAS COMPLETED: THE AIMING ARM WAS NOT RETURNED FOR INVESTIGATION. THE RETURNED NAIL WAS FOUND TO HAVE THE LOCKING MECHANISM DEPLOYED. BECAUSE OF THIS THE HELICAL BLADE WAS UNABLE TO PASS THROUGH THE NAIL. THE PROXIMAL LOCKING HOLE ON THE NAIL HAS DAMAGE AROUND BOTH SURFACES, WHICH IS LIKELY RELATED TO USE OF THE INCORRECT AIMING ARM AND ATTEMPTING TO FORCE THE BLADE INTO THE NAIL. THE RETURNED BLADE HAS SURFACE WEAR WHICH IS LOCATED DISTAL TO THE NECK, WHICH IS CONSISTENT WITH ATTEMPTING TO INSERT A BLADE INTO A NAIL WITH THE LOCKING MECHANISM ALREADY DEPLOYED. A VISUAL INSPECTION, DRAWING REVIEW AND DEVICE HISTORY RECORD REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED AND THE INABILITY TO PASS THE BLADE THROUGH THE NAIL WAS REPLICATED. NO ADDITIONAL MALFUNCTIONS WERE OBSERVED DURING INVESTIGATION. THE RELEVANT DRAWINGS WERE REVIEWED DURING INVESTIGATION. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE ISSUE IS LIKELY RELATED TO USE OF THE INCORRECT AIMING ARM, AS STATED IN THE COMPLAINT, AS WELL AS ATTEMPTING TO INSERT THE BLADE WITH THE LOCKING HEAD ELEMENT DEPLOYED IN THE NAIL. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE THE HELICAL BLADE WOULD NOT GO THROUGH THE NAIL. AS THE BLADE WAS BEING HAMMERED IT WOULD NOT GO IN THROUGH THE NAIL. THE SURGEON REMOVED THE BLADE AND NAIL AND TRIED THE BLADE/NAIL INSERTION AT THE BACK TABLE AND AGAIN IT WOULD NOT WORK. IT WAS DISCOVERED THAT THE AIMING ARM BEING USED WAS INCORRECT. THE NAIL IS A 130 DEGREE NAIL AND THE AIMING ARM USED WAS 125 DEGREE AIMING ARM. THE SURGEON DID NOT WANT TO USE THE SAME IMPLANTS AS HE BELIEVED THEY WERE DAMAGED DURING THE FAILED BLADE INSERTION ATTEMPT. A NEW NAIL AND BLADE WERE USED TO COMPLETE THE PROCEDURE. THE REPORTED EVENT RESULTED IN A 10 MINUTE SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233119 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT H260892

    Patients

    Seq Age Sex Outcome Treatment
    1