BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 LONG NAIL LEFT D10XL380MM X 125DEG

    MDR report key: 17712463 · Received September 8, 2023

    Report

    Report Number
    0009610622-2023-00303
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 15, 2023
    Report Date
    November 27, 2023
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    UDI-DI
    07613327477627
    PMA / PMN Number
    K213328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE BROKEN NAIL WAS RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE NAIL WAS COMPLETELY BROKEN IN THE THINNED WEBS OF THE PROXIMAL DRILL HOLE FOR THE LAG SCREW. THE APPEARANCE OF THE BREAKAGE SURFACES IDENTIFIED THE NAIL HAD BROKEN IN FATIGUE MANNER ¿ INDICATED BY LINES OF REST AND MISSING PLASTIC DEFORMATION. THE INCIPIENT CRACK HAD STARTED AT THE SMALLEST CROSS SECTION AT LATERAL IN THE ANTERIOR WEB AND HAD PROGRESSED TOWARDS MEDIAL. IN THIS AREA THE EDGE WAS DAMAGED BY DRILL MARKS. THIS WAS CAUSED INTRA-OPERATIVELY BY CONTACT WITH THE STEP DRILL WHILE PREPARING THE CANNULATION FOR THE LAG SCREW. REMOVED MATERIAL HAD WEAKENED THE MATERIAL SIGNIFICANTLY. ADDITIONALLY, A 2ND MATERIAL DAMAGE WAS FOUND BELOW ABOVE DRILL MARK. MANUFACTURING AND INSPECTION RECORDS CONFIRMED THE ITEM HAD BEEN RELEASED IN ACCORDANCE TO SPECS. ALTHOUGH THE NAIL WAS BROKEN A PIN GAUGE OHL DID NOT PASS THE PROXIMAL DRILL HOLE. DIMENSIONAL INSPECTION ON THE RETURNED ITEM REVEALED NO SAFE VALUES DUE TO DEFORMATIONS CAUSED BY THE BREAKAGE. THE RAW MATERIAL CERTIFICATE CONFIRMED THE MATERIAL TO BE THE SAME AS DEFINED ON THE DRAWING AND TO THE INTERNAL MATERIAL SPECIFICATION. ABOVE DATA HAD ADDITIONALLY BEEN CONFIRMED BY MANDATORY EXAMINATION PRIOR TO MANUFACTURING. 1 UNDATED X-RAY COPY IN A-P-VIEW WAS PROVIDED SHOWING THE BROKEN NAIL AND THE BONE BREAKAGE. NO OTHER MEDICAL INFORMATION WAS PROVIDED. WITH ONLY 1 MEDICAL DOCUMENT, IN ONE PLANE, A THOROUGH MEDICAL REVIEW WAS NOT POSSIBLE. IF MORE INFORMATION IS PROVIDED, WE RESERVE THE RIGHT TO RE-OPEN THE CASE AND TO RE-ASSIGN THE ROOT CAUSE. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. WITH AVAILABLE INFORMATION A DEFICIENCY OF THE IMPLANT WAS NOT VERIFIED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY ON A GAMMA 4 NAIL ON WAS PERFORMED A FEW MONTHS AFTER THE INITIAL SURGERY. THE NAIL BROKE RIGHT AT THE LAG SCREW INTERFACE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY ON A GAMMA 4 NAIL ON WAS PERFORMED A FEW MONTHS AFTER THE INITIAL SURGERY. THE NAIL BROKE RIGHT AT THE LAG SCREW INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242720 G4 LONG NAIL LEFT D10XL380MM X 125DEG ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH K0C4023 07613327477627

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Unknown Required Intervention