BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø12X170MM X 125°

    MDR report key: 3842523 · Received June 2, 2014

    Report

    Report Number
    0009610622-2014-00251
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IN THIS CASE MANUFACTURING DOCUMENTS AND PRODUCT EXAMINATION REVEALED NO DEVIATION. THE REVIEW OF THE RISK ANALYSIS REVEALED THAT LAG SCREW MIGRATION (CUT-OUT / BACK-OUT) HAD BEEN CONSIDERED. THE OCCURRENCE THRESHOLD WAS NOT EXCEEDED. AVAILABLE X-RAYS LED TO THE SUGGESTION THAT THE PATIENT¿S CONDITION (SUBSIDED FEMUR NECK WITH ROTATION) HAD CONTRIBUTED TO THE EVENT. A DISCREPANCY OF THE PRODUCT WAS NOT VERIFIED BY MANUFACTURING DOCUMENTS, EXAMINATION OF PRODUCTS NEITHER VISIBLE ON X-RAY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT SURGERY FOR A FRACTURE AND HAD A THE G3 NAIL IMPLANTED. ON (B)(6) 2014, THE SURGEON CONFIRMED BY X-RAY THAT THE LAG SCREW HAD PENETRATED THE FEMORAL HEAD AND HAD REACHED THE PELVIS. THE SURGEON IS PLANNING A REVISION SURGERY ON (B)(6) 2014. THE PATIENT WILL BE REVISED TO A THA.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT SURGERY FOR A FRACTURE AND HAD A THE G3 NAIL IMPLANTED. ON (B)(6) 2014, THE SURGEON CONFIRMED BY X-RAY THAT THE LAG SCREW HAD PENETRATED THE FEMORAL HEAD AND HAD REACHED THE PELVIS. THE SURGEON IS PLANNING A REVISION SURGERY ON (B)(6) 2014. THE PATIENT WILL BE REVISED TO A THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320964 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø12X170MM X 125° IMPLANT HSB STRYKER TRAUMA KIEL K111681

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention