BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°

    MDR report key: 4123918 · Received September 27, 2014

    Report

    Report Number
    0009610622-2014-00507
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    July 23, 2007
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF MANUFACTURING DOCUMENTS REVEALED NO DEVIATION IN THE MANUFACTURING PROCESS. THE REVIEW OF THE RISK ANALYSIS REVEALED NO OBSERVATION; POTENTIAL IMPLANT MATTER WAS CONSIDERED AND THRESHOLD - IN CASE OF IMPLANT FAILURE - WAS NOT EXCEEDED. INVESTIGATION REVEALED NO NON-CONFORMITY; THEREFORE NO NEW CAPA WAS INITIATED. REFERRING TO THE EVENT DESCRIPTION THE PATIENT HAD SUFFERED FROM AN ADDITIONAL BONE FRACTURE APPROX. 4 MONTHS AFTER INITIAL IMPLANTATION. X-RAYS CONFIRMED THAT ADDITIONAL BONE BREAKAGE WAS NOT DIRECTLY BELOW THE NAIL. NAIL AND ASSOCIATED IMPLANTS DID NOT SHOW ANY FAULTS OR KIND OF MALFUNCTION. THUS, IT WAS CONCLUDED THAT THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE DEVICE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED EXACTLY BUT REFERRING TO THE DISTANCE BETWEEN NAIL AND ADDITIONAL BONE BREAKAGE IT WAS SUGGESTED THAT THE BONE BREAKAGE WAS RATHER PATIENT RELATED. THE REPORTED INFORMATION DID NOT ALLEGE ANY DEFICIENCY IN THE IDENTITY, QUALITY, RELIABILITY, SAFETY, EFFECTIVENESS OR PERFORMANCE OF THE DEVICE ¿ NEITHER DID THE REVIEW OF PROVIDED X-RAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A MEDICAL EXPERT REVIEW OF THE GAMMA 3 FOLLOW UP DOCUMENTATION THAT A FEMALE PATIENT WHO HAD PREVIOUSLY UNDERGONE IMPLANTATION WITH A TROCHANTERIC NAIL KIT ON (B)(6) 2007 ALLEGEDLY PRESENTED WITH A DISTAL FEMORAL FRACTURE (UNDER THE GAMMA NAIL) ON (B)(6) 2007 WHICH REQUIRED REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A MEDICAL EXPERT REVIEW OF THE GAMMA 3 FOLLOW UP DOCUMENTATION THAT A FEMALE PATIENT WHO HAD PREVIOUSLY UNDERGONE IMPLANTATION WITH A TROCHANTERIC NAIL KIT ON (B)(6) 2007 ALLEGEDLY PRESENTED WITH A DISTAL FEMORAL FRACTURE (UNDER THE GAMMA NAIL) ON (B)(6) 2007 WHICH REQUIRED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603786 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K782657

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention