BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 125°

    MDR report key: 3931071 · Received July 14, 2014

    Report

    Report Number
    0009610622-2014-00323
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REVIEW OF MANUFACTURING DOCUMENTS REVEALED NO DEVIATION IN THE MANUFACTURING PROCESS. THE REPORTED EVENT INDICATED THAT THE LAG SCREW HAD FULFILLED ITS TASKS ¿ TEMPORARY STABILIZATION OF A BONE FRACTURE ¿ FOR A PERIOD OF NEARLY 9 MONTHS. AS NO PRE- AND POST-OPERATIVE X-RAYS WERE PROVIDED THE INITIAL IMPLANT POSITIONS AND THE COURSE OF BONE HEALING COULD NOT BE DETERMINED. THE NAIL (INCLUDING THE LAG SCREW) DID NOT SHOW ANY DEFICIENCIES ON RECEIVED X-RAY. HOWEVER, RECEIVED X-RAY REVEALED THAT THE LAG SCREW WAS STICKING OUT SIGNIFICANTLY AT LATERAL. IT WAS SUGGESTED THAT THE LAG SCREW WAS EITHER INITIALLY TOO LONG OR IT HAD MOVED HAD MOVED TOWARDS LATERAL DURING THE IMPLANTATION PERIOD. LATERALIZATION IS A FEATURE OF THE GAMMA-SYSTEM ¿ BUT IN A CONTROLLED, DEFINED MANNER. AFTER HAVING CHANGED THE CONTRAST OF THE X-RAY SHOWING THE PROXIMAL PART OF THE FEMUR IT APPEARED THAT THE SET SCREW OF THE NAIL KIT WAS NOT ENGAGED AS INTENDED IN THE SLIDING FLUTE OF THE LAG SCREW. IT RATHER SEEMED THAT THE LAG SCREW WAS ABLE TO SLIDE IN UNCONTROLLED MANNER. ANOTHER SCENARIO COULD BE THAT THE SURGEON INTENTIONALLY HAD CHOSEN STATIC LOCKING MODE FOR THE LAG SCREW. HOWEVER, BOTH CASES WOULD NOT BE IN ACCORDANCE TO THE OPERATION TECHNIQUE. ACCORDING TO RECEIVED INFORMATION NO FURTHER INFORMATION COULD BE EXPECTED. THE REPORTED INFORMATION DID NOT ALLEGE ANY DEFICIENCY IN THE IDENTITY, QUALITY, RELIABILITY, SAFETY, EFFECTIVENESS OR PERFORMANCE OF THE DEVICE RESULTING IN A MALFUNCTION OR ADVERSE CONSEQUENCE. THE EVENT WAS NOT CAUSED BY ANY DEFICIENCY OF THE DEVICE(S).

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CLINICAL RESEARCH ASSOCIATE, REPORTED THAT A PATIENT IS SUFFERING PAIN FROM THE LAG SCREW. THE THE PATIENT WAS OFFERED REMOVAL OF THE IMPLANT, BUT THEY DID NOT WANT TO RISK ANY FURTHER SURGERY AT THIS TIME.

    Description of Event or Problem · 1

    THE CLINICAL RESEARCH ASSOCIATE, REPORTED THAT A PATIENT IS SUFFERING PAIN FROM THE LAG SCREW. THE THE PATIENT WAS OFFERED REMOVAL OF THE IMPLANT, BUT THEY DID NOT WANT TO RISK ANY FURTHER SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410969 LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K297099

    Patients

    Seq Age Sex Outcome Treatment
    1 Other