BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 95MM

    MDR report key: 5068833 · Received September 10, 2015

    Report

    Report Number
    2520274-2015-15794
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR AS TO WHETHER OR NOT THE DEVICE WAS IMPLANTED, AS IT WAS INDICATED THE DEVICE MAY BE RETURNING FOR INVESTIGATION. 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 INVESTIGATION SUMMARY ¿ ONE TFN Ø10 130° L235 TAN GREEN (PRODUCT NUMBER: 456.325, LOT NUMBER: 7940430, MFG DATE: 13MAR2015; PART 1), ONE HELICAL BLADE F/TFN Ø11 L95 TAN GOLD (PRODUCT NUMBER: 456.304, LOT NUMBER: 7991237, MFG DATE: 25APR2015; PART 2), ONE HELICAL BLADE F/TFN Ø11 L95 TAN GOLD (PRODUCT NUMBER: 456.304, LOT NUMBER: 7991237, MFG DATE: 25APR2015; PART 3), AND ONE INSERT-HANDLE F/TFN (PRODUCT NUMBER: 357.411, LOT NUMBER: 6694869, MFG DATE: 15AUG2011; PART 4) WAS RECEIVED. UPON VISUAL INSPECTION OF ALL COMPLAINT DEVICES THERE ARE CLEAR INDENTATION MARKS THROUGHOUT EACH DEVICE THAT WAS MOST LIKELY CAUSED BY A LOT OF FORCE TRYING TO INSERT THE HELICAL BLADE INTO THE NAIL. PARTS 1 AND 4 (INSERTION HANDLE AND NAIL) ARE COLD WIELDED TOGETHER AND CANNOT BE REMOVED; THIS IS MOST LIKELY CAUSED BY OVER ROTATING THE CONNECTING SCREW CAUSING IT TO BECOME STUCK. FOR PART 1 THERE IS SEVERE DAMAGE AROUND THE PROXIMAL END WHERE THE HELICAL BLADE IS TO BE INSERTED. FOR PART 2 THERE ARE DAMAGED SECTIONS THROUGHOUT THE BLADE. FOR PART 3 THERE ARE MINOR DAMAGE THROUGHOUT THE BLADE. A ROOT CAUSE COULD NOT BE DETERMINED; THE COMPLAINT CONDITION FOR PARTS 1-3 MAY HAVE BEEN CAUSED BY THE NAIL ROTATING AS STATED IN THE COMPLAINT DESCRIPTION AND THE SURGEON TRYING TO A FREE HAND TECHNIQUE TO INSERT THE HELICAL BLADE(S) INTO THE NAIL UNDER POWER CAUSING THE COMPLAINT CONDITION. AND FOR PART 4 THERE ARE INDENTATION MARKS NEAR WHERE THE DRIVING CAP IS SUPPOSED TO ATTACH, THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF HAMMERING ON THE DRIVING CAP TO DRIVE THE NAIL INTO THE PATIENT¿S ANATOMY THROUGH THE USE OF THE INSERTION HANDLE. A ROOT CAUSE COULD NOT BE DETERMINED; IT MAY HAVE BEEN A RESULT OF OVER TORQUE THE CONNECTING SCREW CAUSING THE HANDLE TO BECOME STUCK ONTO THE NAIL. THE COMPLAINT IS CONFIRMED. THE DEVICE DRAWING ((B)(4)) WAS REVIEWED. THE DESIGN HISTORY WAS FOUND TO NOT 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 PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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

    (B)(6). PART MANUFACTURE DATE: 25APRIL2015. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THE DEVICE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. NOT EXPLANTED. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE PHYSICIAN TRIED TO PLACE THE SECOND BLADE BUT HE COULD NOT PLACE THE BLADE INTO THE NAIL.

    Description of Event or Problem · 1

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AS THE SURGEON BEGINS THE SURGERY, THE SURGEON FEELS RESISTANCE TO PLACE NAIL INTO THE PATIENT'S BONE, HE DECIDES RHYME THE PROXIMAL FEMUR PART, FOR THE TFN NAIL TO PASS EASILY WITHIN THE PATIENT'S BONE, HOWEVER HE STILL FEELS RESISTANCE PLACING THE NAIL BUT HE MANAGED TO ENTER THE NAIL INTO THE BONE OF THE PATIENT. WHEN THE SURGEON WANTS TO PLACE THE HELICAL BLADE, THE BLADE DOES NOT ENTER INTO THE NAIL. THE SURGEON DECIDES REMOVE WITH DIFFICULTY THE NAIL AND HE SEES THAT THE NAIL WAS ROTATED FROM ITS ORIGINAL POSITION AND THE PROXIMAL HOLE OF THE NAIL FOR WHERE THE SCREW CONNECTION SETS WAS DAMAGED. THE INSERTION HANDLE CANNOT REMOVE OF THE NAIL, NO PROLONGATION IN SURGERY REPORTED. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598747 11.0MM TI HELICAL BLADE 95MM ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 7991237

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR