BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 125°

    MDR report key: 4202689 · Received October 27, 2014

    Report

    Report Number
    0009610622-2014-00566
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 2, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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

    REFERRING TO PRODUCT INQUIRY THE TROCHANTERIC NAIL KIT, STST GAMMA3 Ø11X180MM X 125° IS STATED TO BE THE PRIMARY PRODUCT. THE LAG SCREW, THE LOCKING SCREW AS WELL AS THE END CAP REPORTED ARE CONSIDERED ASSOCIATED PRODUCTS. FAILURES IN MATERIAL OR MANUFACTURING OF THE AFFECTED NAIL KIT RETURNED WERE NOT FOUND. DIMENSIONAL EXAMINATION REVEALED NO DEVIATIONS IN THE RELEVANT UNDAMAGED AREAS OF THE NAIL RETURNED. THE AFFECTED ITEM WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THUS, WE EXCLUDE DEVIATIONS IN MATERIAL AND MANUFACTURING. THE RECEIVED NAIL IS COMPLETELY BROKEN IN THE WEBS OF THE PROXIMAL DRILL HOLE FOR THE LAG SCREW. ACCORDING TO THE DAMAGE AND THE EVIDENCES OF THE BREAKAGE SURFACES, THE NAIL BROKE IN A FATIGUE FRACTURE DUE TO AXIAL OVERLOAD AFTER AN IMPLANTATION PERIOD OF APPROX. 27 MONTHS. MATERIAL DEFORMATION AT THE MEDIAL / DISTAL AND THE LATERAL / PROXIMAL EDGE OF THE LAG SCREW HOLE INDICATES HIGH TENSION FORCES CAUSED BY HIGH AXIAL LOAD - TRANSMITTED BY THE LAG SCREW, WHICH SUGGESTS HIGH / PERMANENT WEIGHT BEARING. THE COUNTERPARTS WERE FOUND ON THE LAG SCREW IN THE AREAS WITH FRICTION SIGNS WHERE THE EDGES OF THE SLIDING GROOVES HAD BECOME WORN. FURTHERMORE, DUE TO THE TRACES FOUND AT THE LATERAL EDGE OF THE PROXIMAL BORE AND AT THE INSIDE OF THE POSTERIOR WEB, IT CAN BE CONCLUDED THAT THE NAIL BREAKAGE WAS CONTRIBUTED BY INTRA-OPERATIVE DAMAGE CAUSED BY A DEVIATED STEP DRILL. THE IFU DESCRIBES THAT THE IMPLANTS ARE NOT INTENDED TO REPLACE NORMAL BONE STRUCTURES; THEY ARE NOT AS STRONG, RELIABLE OR DURABLE AS A NORMAL HUMAN BONE. THE IMPLANTS CAN BREAK OR BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY OR TRAUMA. FURTHERMORE IT IS DESCRIBED THAT THE IMPLANTS HAVE A FINITE EXPECTED SERVICE LIFE / LONGEVITY AND MAY NEED TO BE REMOVED AT SOME TIME IN THE FUTURE. THE AFFECTED IMPLANT IS DESIGNED TO WITHSTAND THE NORMAL LOADS DURING THE IMPLANTATION PERIOD, I.E., THE IMPLANT MUST NEITHER BE EXPOSED TO PEAK LOADS NOR TO CONTINUOUS STRESSES. ANOTHER PREREQUISITE FOR A SUCCESSFUL SUPPLY IS UNDISTURBED, NORMAL BONE HEALING. THIS STATE MUST BE ACHIEVED WITHIN A MEDICALLY RECOGNIZED PERIOD (CONFIRMED BY SCIENTIFIC ANALYSIS ABOUT 6 MONTHS) IN SUCH WAY, THAT THE BONE STRENGTH ALLOWS SIGNIFICANTLY INCREASING DISCHARGE OF THE TIME-FIXED IMPLANT MATERIAL. IN CASE THAT SUCH A SITUATION DOES NOT OCCUR, EXCEEDING OF THE FATIGUE STRENGTH IS TO BE EXPECTED AND THUS QUITE PREDICTABLE COMPLICATIONS. MEDICAL DATA (PRE-, INTRA, POST OP X-RAYS AS WELL AS OP-REPORTS) WERE REQUESTED BUT NOT AVAILABLE. RESULTS OF RECOMMENDED REGULAR FOLLOW-UP EXAMINATION WERE NOT PROVIDED; THUS THE COURSE OF BONE HEALING COULD NOT BE DETERMINED. IT COULD NOT BE DETERMINED WHETHER THE PATIENT HAD BEEN COMPLIANT TO THE SURGEON¿S POST-OPERATIVE INSTRUCTIONS. BASED ON THE ABOVE THE NAIL BREAKAGE IS NOT LINKED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER CONSIDERED PATIENT RELATED WITH REGARDS TO AN IMPLANTATION PERIOD OF APPROX. 27 MONTHS. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE G3 NAIL WAS BROKEN. THIS CONFIRMED BY THE HOSPITAL ON XRAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE G3 NAIL WAS BROKEN. THIS CONFIRMED BY THE HOSPITAL ON XRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684349 TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K1117998

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention