BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 LONG NAIL RIGHT D10XL360MM X 125DEG

    MDR report key: 17057006 · Received June 5, 2023

    Report

    Report Number
    0009610622-2023-00190
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    May 9, 2023
    Report Date
    September 5, 2023
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    UDI-DI
    07613327479447
    PMA / PMN Number
    K213328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE ITEM WAS RETURNED IN BROKEN CONDITION. 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. PROVIDED X-RAYS WERE FORWARDED TO A MEDICAL EXPERT FOR REVIEW: HIS COMMENTS (IN EXTRACTS): THERE WAS ¿ EVIDENCE OF POOR BONE REPAIR CAPACITY DUE TO POOR VASCULARIZATION. ¿ IF THE (LAG SCREW) SCREW ORIENTATES CLEARLY DIFFERENT FROM THE ORIENTATION OF THE FEMORAL NECK THIS MIGHT RESULT IN ADDITIONAL SHEAR LOAD DURING THE MOVEMENT OF THE HEAD WHEN THE PATIENT WALKS. THIS CAN RESULT IN A NON-UNION. ACCORDING TO RECEIVED INFORMATION THE PATIENT WAS NOT COMPLIANT TO THE SURGEON¿S MOBILIZATION INSTRUCTIONS. THE PATIENT EXPERIENCED SUB-TROCH NON-UNION AND FELL AND THE G4 NAIL BROKE. INVESTIGATION REVEALED NO DEFICIENCY OF THE PRODUCT. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A PATIENT RELATED ISSUE. IF ANY INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    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

    AS REPORTED: "GAMMA 4 NAIL IMPLANTED 5 MONTHS AGO. PATIENT HAD SUB-TROCH NON-UNION AND FELL, GAMMA 4 NAIL BROKE. PATIENT NEVER HEALED AND WAS ALLOWED TO 'WAIT THERE' FOR THE SURGEON AND PA." IT WAS ALSO REPORTED THAT THERE WAS AN INFECTION, AND THE PATIENT WAS REVISED.

    Description of Event or Problem · 0

    AS REPORTED: "GAMMA 4 NAIL IMPLANTED 5 MONTHS AGO. PATIENT HAD SUB-TROCH NON-UNION AND FELL, GAMMA 4 NAIL BROKE. PATIENT NEVER HEALED AND WAS ALLOWED TO 'WAIT THERE' FOR THE SURGEON AND PA." IT WAS ALSO REPORTED THAT THERE WAS AN INFECTION, AND THE PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29776 G4 LONG NAIL RIGHT D10XL360MM X 125DEG ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH 8425-0360S K02A541 07613327479447

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention