BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120°

    MDR report key: 8735323 · Received June 26, 2019

    Report

    Report Number
    0009610622-2019-00522
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    May 29, 2019
    Report Date
    September 2, 2019
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540375025
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, HOWEVER THE DEVICE WAS NOT RETURNED FOR EVALUATION BUT POST-OPERATIVE X-RAYS WERE PROVIDED WHICH CONFIRMED THE FAILURE MODE. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED, AND NO OTHER EVIDENCE WAS PROVIDED FOR INVESTIGATION. HOWEVER, A CLINICAL STATEMENT WAS REQUESTED FOR THE EVALUATION OF THE PROVIDED MEDICAL DATA. MEDICAL EXPERT CLINICAL STATEMENT: ¿THE X-RAYS SHOWS A PERTROCHANTERIC FEMORAL FRACTURE WITH INVOLVEMENT OF THE LESSER TROCHANTER. THE MEDIAL PROXIMAL WALL SHOWS COMMINUTION WITH LOSS OF ANTERIOR PARTS OF THE CORTEX AROUND THE LESSER TROCHANTER. A GAMMA-NAIL WAS IMPLANTED IN THE RIGHT POSITION. NO ADDITIONAL SURGICAL MEASURES HAVE BEEN TAKEN TO ADDRESS THE DEFECT AT THE MEDIAL SIDE. CONSEQUENTLY, THE FRACTURE DID NOT HEAL AT THE MEDIAL CORTEX AND BIOMECHANICAL STRESS TO THE NAIL CONTINUED. FAILURE OCCURRED ONLY TWO MONTHS AFTER THE IMPLANTATION WHICH HAS TO BE REGARDED AS A VERY EARLY FAILURE. THE AXIAL X-RAY SHOWS A CENTRAL POSITIONING OF THE SCREW WHEREAS THE AP-VIEW IS SHOWING A VERY ECCENTRIC POSITION OF THE SCREW. THIS MAY HAVE CONTRIBUTED TO A HIGHER LOAD AND EARLY FAILURE OF THE NAIL.¿ ALTHOUGH THE PRODUCT WAS NOT RETURNED FOR EVALUATION, BASED ON THE CLINICAL EVALUATION OF THE PATIENT¿S RECORDS & X-RAYS, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED DUE TO SUB-OPTIMAL PROCEDURE FOLLOWED BY THE SURGEON DURING FIXATION OF THE FRACTURE. ALTHOUGH THE NAIL WAS PLACED IN THE CORRECT POSITION, NO ADDITIONAL SURGICAL MEASURES WERE TAKEN TO ADDRESS THE DEFECT AT THE MEDIAL SIDE WHERE THERE WAS COMMINUTION. CONSEQUENTLY, THE FRACTURE DID NOT HEAL AT THE MEDIAL CORTEX AND BIOMECHANICAL STRESS TO THE NAIL CONTINUED. ALSO, SLIGHTLY ECCENTRIC POSITIONING OF THE SCREW LED TO AN UNEVEN LOAD DISTRIBUTION ON THE NAIL. THESE TWO FACTORS COMBINED LED TO AN EARLY FAILURE OF THE NAIL. GENERAL ASPECT: REVISION SURGERY DUE TO IMPLANT FAILURE (CUT OUT, IMPLANT BREAKAGE) IS A TYPICAL COMPLICATION OF PROXIMAL FEMORAL NAILING. THIS HARM DOES NOT PRIMARILY DEPEND ON THE IMPLANT. IT IS MOSTLY CAUSED BY THE KIND OF FRACTURE, PATIENT'S GENERAL CONDITION (OSTEOPOROSIS), AND PRIMARILY THE RESPECTIVE SURGICAL TECHNIQUE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. THE IFU CLEARLY STATES THAT: ¿6 ADVERSE EFFECTS IN MANY INSTANCES, ADVERSE RESULTS MAY BE CLINICALLY RELATED RATHER THAN DEVICE RELATED. ¿ DELAYED UNION OR NON-UNION OF THE FRACTURE SITE. ¿ THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNIONS AND/OR NON-UNIONS. INTERNAL FIXATION DEVICES ARE LOAD SHARING DEVICES WHICH ARE INTENDED TO HOLD FRACTURED BONE SURFACES IN APPOSITION TO FACILITATE HEALING. IF HEALING IS DELAYED OR DOES NOT OCCUR, THE APPLIANCE MAY EVENTUALLY BREAK DUE TO METAL FATIGUE. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND THE PATIENT¿S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE DEVICE. ¿ IMPROPER ALIGNMENT CAN CAUSE A MAL-UNION OF THE BONE AND/OR BENDING, CRACKING OR EVEN BREAKAGE OF THE DEVICE.¿ IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    PHARMACIST REPORTED THAT A GAMMA 3 NAIL, AFTER IMPLANTATION IN A PATIENT ON (B)(6) 2019, BROKE AT THE CERVICAL SCREW. FRACTURE OF THE GREATER TROCHANTER OCCURRED. MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE BROKEN NAIL. PROSTHETIC HIP WAS IMPLANTED DURING RECOVERY SURGERY.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PHARMACIST REPORTED THAT A GAMMA 3 NAIL, AFTER IMPLANTATION IN A PATIENT ON (B)(6) 2019, BROKE AT THE CERVICAL SCREW. FRACTURE OF THE GREATER TROCHANTER OCCURRED. MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE BROKEN NAIL. PROSTHETIC HIP WAS IMPLANTED DURING RECOVERY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528203 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K04EB4B 04546540375025

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention