BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM-STERILE

    MDR report key: 5441914 · Received February 17, 2016

    Report

    Report Number
    3003506883-2016-10035
    Event Type
    Injury
    Date Received
    February 17, 2016
    Report Date
    January 27, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE IMPLANT IS INTACT AND FUNCTIONALLY UNDAMAGED. THERE ARE SLIGHT DISCOLORATIONS AND MINOR SCRATCHES PRESENT THAT ARE CONSISTENT WITH IMPLANTATION AND REMOVAL. THE EXACT CAUSE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED, BUT IT WAS LIKELY A RESULT OF OSTEOPOROTIC BONE DUE TO THE AGE/GENDER OF THE PATIENT. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. DRAWINGS WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). ADDITIONAL DEVICE PRODUCT CODE IS HWC. (B)(4). DATE OF IMPLANT IS UNAVAILABLE FOR REPORTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 9832862 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. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 A TROCHANTERIC FIXATION NAIL (TFN) EXPLANT WITH REVISION TO A TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2016 AFTER IT WAS NOTED THAT A HELICAL BLADE CUT OUT IN THE FEMORAL HEAD. ALL HARDWARE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM OR SURGICAL DELAY. THE ORIGINAL DATE OF IMPLANT IS UNKNOWN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97838 11.0MM TI HELICAL BLADE 100MM-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 9832862

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention