BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X320MM X 125°

    MDR report key: 3946126 · Received July 21, 2014

    Report

    Report Number
    0009610622-2014-00350
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED VIA X-RAYS. THE NAIL AND BOTH DISTAL PLACED LOCKING SCREWS WERE CLASSIFIED AS PRIMARY PRODUCTS DURING INVESTIGATION. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE IMPLANTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AN INVESTIGATION OF THE IMPLANTS WAS NOT POSSIBLE BECAUSE THEY WERE NOT PROVIDED; THE ROOT CAUSE OF THE BREAKAGES IS UNKNOWN. THE RETURNED X-RAYS SHOW THAT THE NAIL BROKE IN ITS PROXIMAL HOLE; FURTHERMORE THE LOCKING SCREW, PLACED IN THE DISTAL ROUND HOLE IS BROKEN. THE LOCKING SCREW PLACED IN THE DISTAL LONG HOLE SEEMS TO BE INTACT. AT MEDIAL AND LATERAL KIND OF GAPS IN THE BONE ARE VISIBLE; IN COMBINATION WITH THE LONG IMPLANTATION TIME OF APPROX. 9 MONTHS A NON-UNION CANNOT BE EXCLUDED. NON-UNIONS CAN LEAD TO IMPLANT BREAKAGES AND ARE LISTED IN THE IFU. MOST LIKELY THE NON-UNION CAUSED THE IMPLANT BREAKAGES. IF OTHER LISTED ADVERSE EFFECTS (OBESITY, POOR BONE QUALITY, DISEASES, WEIGHT BEARING, ETC.) DID CONTRIBUTE TO THE ISSUE COULD NOT BE DETERMINED DUE TO MISSING INFORMATION. BECAUSE NO MANUFACTURER RELATED ISSUES WERE FOUND THE CASE IS ATTRIBUTED TO PATIENT CONDITIONS. NO NON-CONFORMITY IDENTIFIED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 GAMMA3 LONG NAIL SURGERY WAS PERFORMED. THREE MONTHS AFTER THE SURGERY, REHABILITATION IS STARTED. NINE MONTHS AFTER THE SURGERY, NAIL BREAKAGE AND DISTAL LOCKING SCREW BREAKAGE WERE FOUND BY X-RAYS. ON (B)(6) 2014, REVISION SURGERY WAS PERFORMED. A PART OF BROKEN DISTAL LOCKING SCREW REMAINED IN THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013 GAMMA3 LONG NAIL SURGERY WAS PERFORMED. 3 MONTHS AFTER THE SURGERY, REHABILITATION IS STARTED. 9 MONTHS AFTER THE SURGERY, NAIL BREAKAGE AND DISTAL LOCKING SCREW BREAKAGE WERE FOUND BY X-RAYS. ON (B)(6) 2014, REVISION SURGERY WAS PERFORMED. A PART OF BROKEN DISTAL LOCKING SCREW REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425026 LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X320MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K182528

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention