BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM

    MDR report key: 4950086 · Received July 29, 2015

    Report

    Report Number
    3003506883-2015-10120
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    July 17, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. PER FACILITY, THE COMPLAINANT PART IS THE PATIENT¿S PROPERTY AND WILL NOT BE RETURNED FOR INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURING DATE: SEPTEMBER 25, 2014. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE DHR SHOWS LOT 7800721 (11.0MM TI HELICAL BLADE) 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. A REVIEW OF THE RAW MATERIAL DHR REVEALED THIS LOT MET ALL SPECIFICATIONS EXCEPT THAT THE ORIGINAL CERTIFICATION HAD BETA TRANSUS LISTED IN FAHRENHEIT INSTEAD OF CELSIUS. THIS DOCUMENTATION ERROR WAS CORRECTED AND WOULD NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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 AN OBESE PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE ON (B)(6) 2015. ON AN UNKNOWN DATE THEREAFTER, THE SURGEON NOTED THAT THE IMPLANTED HARDWARE APPEARED TO BE SLIGHTLY POSTERIOR AND IT APPEARED AS THOUGH THE IMPLANT HAD SLIPPED OUT OF THE FEMORAL HEAD. AS X-RAYS WERE DIFFICULT TO READ, THE SURGEON ORDERED A CAT SCAN, WHICH CONFIRMED THAT THE IMPLANTED TFN IMPLANT HAD SLIPPED OUT OF THE FEMORAL HEAD. IT WAS UNCLEAR IF THE TFN WAS IMPLANTED SLIGHTLY POSTERIOR OR IF IT MIGRATED WHEN THE PATIENT BEGAN WEIGHT BEARING. THE SURGEON, WITH THE CONSULT OF TWO OTHER PHYSICIANS, OPTED TO REVISE THE PATIENT BY REMOVING THE TFN IMPLANT ON (B)(6) 2015. IT WAS REPORTED THAT, AT THIS TIME, THE PATIENT IS NOT A CANDIDATE FOR A TOTAL HIP REPLACEMENT DUE TO OBESITY. IT WAS REPORTED THAT, AFTER HEALING AND RECOMMENDED WEIGHT LOSS, THE PATIENT MAY BE A POSSIBLE CANDIDATE FOR THAT PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAYS OR HARM TO THE PATIENT. THE PATIENT STATUS WAS REPORTED AS UNKNOWN AS THE SURGERY HAD JUST BEEN COMPLETED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493413 11.0MM TI HELICAL BLADE 100MM ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 7800721

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention