BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING

    MDR report key: 6099886 · Received November 14, 2016

    Report

    Report Number
    3003875359-2016-10592
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. CONCOMITANT DEVICES REPORTED: TITANIUM SPIRAL BLADE 60MM FOR TITANIUM RETROGRADE FEMORAL NAILS-EX (PART # 04.013.044, LOT # UNKNOWN, QUANTITY #1), 5.0MM TITANIUM LOCKING SCREW W/T25 STARDRIVE 60MM FOR INTRAMEDULLARY NAILS (PART # 04.005.550, LOT # UNKNOWN, QUANTITY #1), 13MM TITANIUM CANNULATED RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE (PART # 04.013.756S, LOT # 7950170, QUANTITY #1), STANDARD INSERTION HANDLE (PART # 03.010.045, LOT # 1679894, QUANTITY #1), 15.0MM/13.0MM PROTECTION SLEEVE F/SPIRAL BLADE AIMING ARM (PART # 03.010.081, LOT # 1551624, QUANTITY #1), 13.0MM/3.2MM WIRE GUIDE FOR SPIRAL BLADE AIMING ARM (PART # 03.010.082, LOT # 1589718, QUANTITY #1), 3.2MM GUIDE WIRE 290MM (PART # 03.010.115, LOT # UNKNOWN, QUANTITY #1), CONNECTING SCREW FOR INSERTER FOR TITANIUM SPIRAL BLADES (PART # 357.34, LOT # 5230357, QUANTITY #1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE (PART # 03.010.044, LOT # UQ61677, QUANTITY #1). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE LOT. PART # 03.010.051, LOT # 5545163, SERIAL/SUPPLIER LOT # (B)(4). MANUFACTURING LOCATION: MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 08 JUNE 2007 . NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    COMPLAINANT PART IS NO LONGER EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE RETURN PACKAGE WAS RECEIVED DAMAGED AND THE DEVICE WAS NO LONGER INSIDE. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. SIX PARTS WERE RECEIVED FOR EVALUATION. THE 5 OF THE 6 DEVICES ARE CONSIDERED CONCOMITANT DEVICES. PART # 03.010.084 IS THE ONLY DEVICE RETURNED WITH A COMPLAINT ALLEGATION. THE 03.010.051 AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING WAS NOT RETURNED FOR EVALUATION AND THEREFORE THE COMPLAINT CONDITION OF "DEVICE INTERACTION: MISALIGNMENT" COULD NOT BE CONFIRMED FOR THIS DEVICE. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED FOR THE RETURNED DEVICE AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE FOLLOWING 5 PARTS WERE RETURNED AS CONCOMITANT DEVICES WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THESE DEVICES CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THESE DEVICES. STANDARD INSERTION HANDLE (PART # 03.010.045, LOT # 1679894, QUANTITY #1), 15.0MM/13.0MM PROTECTION SLEEVE F/SPIRAL BLADE AIMING ARM (PART # 03.010.081, LOT # 1551624, QUANTITY #1), 13.0MM/3.2MM WIRE GUIDE FOR SPIRAL BLADE AIMING ARM (PART # 03.010.082, LOT # 1589718, QUANTITY #1), CONNECTING SCREW FOR INSERTER FOR TITANIUM SPIRAL BLADES (PART # 357.34, LOT # 5230357, QUANTITY #1), CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE (PART # 03.010.044, LOT # UQ61677, QUANTITY #1). 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 DURING THE INITIAL INSERTION OF A RETROGRADE FEMORAL NAIL ON (B)(6) 2016, THE SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX BECAME DAMAGED (THE TEETH WERE BENT AND SHORTENED) AND THE SPIRAL BLADE WAS UNABLE TO BE FULLY SEATED ON THE INSERTER. IN ADDITION, THE AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING SLEEVES LOOKED LOOSE ACCORDING TO THE SURGEON AND THIS CAUSED THE DISTAL SCREW TO MISS THE NAIL. AS A RESULT, SURGERY WAS DELAYED APPROXIMATELY TWENTY (20) MINUTES. THE SPIRAL BLADE WAS INSERTED USING THE INSERTER AFTER BENDING THE TEETH. THE SPIRAL BLADE WAS NOT ABLE TO BE SEATED FLUSH BUT THE SURGEON INSERTED IT UNDER X-RAY TO ENSURE PROPER PLACEMENT. THE SPIRAL BLADE WAS CENTERED IN THE NAIL AS SPECIFIED BY THE TECHNIQUE GUIDE. THE IMPLANTS WERE IMPLANTED AND THE SURGEON WAS SATISFIED. NO REPORTED PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: TITANIUM SPIRAL BLADE 60MM FOR TITANIUM RETROGRADE FEMORAL NAILS-EX (PART # 04.013.044, LOT # UNKNOWN, QUANTITY #1), 5.0MM TITANIUM LOCKING SCREW W/T25 STARDRIVE 60MM FOR INTRAMEDULLARY NAILS (PART # 04.005.550, LOT # UNKNOWN, QUANTITY #1), 13MM TITANIUM CANNULATED RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE (PART # 04.013.756S, LOT # 7950170, QUANTITY #1), STANDARD INSERTION HANDLE (PART # 03.010.045, LOT # 1679894, QUANTITY #1), 15.0MM/13.0MM PROTECTION SLEEVE F/SPIRAL BLADE AIMING ARM (PART # 03.010.081, LOT # 1551624, QUANTITY #1), 13.0MM/3.2MM WIRE GUIDE FOR SPIRAL BLADE AIMING ARM (PART # 03.010.082, LOT # 1589718, QUANTITY #1), 3.2MM GUIDE WIRE 290MM (PART # 03.010.115, LOT # UNKNOWN, QUANTITY #1), CONNECTING SCREW FOR INSERTER FOR TITANIUM SPIRAL BLADES (PART # 357.34, LOT # 5230357, QUANTITY #1) CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE (PART # 03.010.044, LOT # UQ61677, QUANTITY #1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750885 AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING GUIDE FZX SYNTHES HAGENDORF 1690974

    Patients

    Seq Age Sex Outcome Treatment
    1 # 03.010.044| 03.010.045| 03.010.081| 03.010.082| 03.010.115| 04.005.550| 04.013.044,| 04.013.756S| 357.34