BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM-STERILE

    MDR report key: 4424126 · Received January 15, 2015

    Report

    Report Number
    3003506883-2015-10024
    Event Type
    Injury
    Date Received
    January 15, 2015
    Report Date
    December 27, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S INITIALS ARE (B)(6). EVENT DATE: UNKNOWN. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. LOT EXPIRY IS JULY 2018. DATE OF ORIGINAL IMPLANT IS UNKNOWN. PER FACILITY, DEVICE WILL NOT BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURE DATE: SEPT 2, 2009 ¿ EXPIRY DATE: JULY 2018 A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE DHR SHOWS LOT 6201861 OF 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 DEVICE HISTORY RECORD REVEALED THIS LOT (5892638) MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. 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 THE PATIENT HAD A TROCHANTERIC FIXATION NAIL (TFN) IMPLANTED ON AN UNKNOWN DATE. ON (B)(6) 2014, THE TFN, HELICAL BLADE, AND ONE 5.0MM LOCKING SCREW WERE REMOVED, DUE TO INFECTION, PAIN, IRRITATION AND DISCOMFORT. THE PATIENT WAS REVISED TO A GRIDLESTONE. NO ALLEGATIONS WERE REPORTED AGAINST THE REMOVED IMPLANTS AND THE EXPLANT SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT¿S STATUS/OUTCOME WAS REPORTED AS ¿OKAY.¿ NO SURGICAL DELAY WAS REPORTED. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36208 11.0MM TI HELICAL BLADE 100MM-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 6201861

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention