BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM X 125°

    MDR report key: 4740137 · Received April 30, 2015

    Report

    Report Number
    0009610622-2015-00218
    Event Type
    Injury
    Date Received
    April 30, 2015
    Date of Event
    April 3, 2015
    Report Date
    April 15, 2015
    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

    INVESTIGATION SUMMARY:EVALUATION REVEALED THE LONG GAMMA NAIL TO BE THE PRIMARY PRODUCT. ALL OTHER MENTIONED PRODUCTS ARE REGARDED TO BE CONCOMITANT ITEMS. A REVIEW OF THE DHR REVEALED NO DISCREPANCIES IN MATERIAL OR MANUFACTURING. DISCUSSION OF THE DAMAGES OBSERVED ON PRIMARY PRODUCT: NAIL: DAMAGE AND EVIDENCE OF THE BREAKAGE SURFACES, COURSE OF THE BREAKAGE LINE AS WELL AS THE ABSENCE OF PLASTIC DEFORMATION (ALONG THE BREAKAGE LINE) SUGGEST THAT THE IMPLANT FRACTURED IN A FATIGUE MANNER DUE TO OVERLOAD. EVIDENT LINES OF REST FOUND ON BOTH FRAGMENTS INDICATE A FATIGUE FRACTURE OF THE NAIL RUNNING FROM LATERAL TO MEDIAL. APPEARANCE OF THE BREAKAGE SURFACES, AS WELL AS THE COURSE OF THE BREAKAGE LINE, WORN AREAS AND MATERIAL DISPLACEMENT IN OUTSIDE DIRECTION SUGGESTS THAT MOST LIKELY THE FATIGUE FRACTURE STARTED IN THE ANTERIOR WEB AND WITH A CERTAIN DELAY IN THE POSTERIOR WEB AS WELL. BENT OUTWARD MATERIAL AND STRUCTURE OF THE BREAKAGE SURFACE SUGGESTS THE RESIDUAL (FORCED-FRACTURE) BEING LOCATED AT THE MEDIAL TIPS OF THE POSTERIOR WEB. EVIDENT MATERIAL ABRASION AND DEFORMATION (FRICTION MARKS IN THE SCREW HOLE) WERE IDENTIFIED AS COLD SETS (FRETTING CORROSION), WHICH WERE CAUSED BY HIGH LOAD BEARING WITH THE LAG SCREW DURING THE PERIOD OF IMPLANTATION. THE LATERAL EDGE OF THE ANTERIOR WEB OF THE PROXIMAL DRILL HOLE HAD BECOME SIGNIFICANTLY DAMAGED DUE TO CONTACT WITH THE LAG SCREW STEPDRILL. SUCH ¿ NOT INTENDED ¿ MATERIAL DAMAGES CAN CAUSE ADDITIONAL NOTCH EFFECTS. DISTAL DRILL HOLES: DAMAGE OBSERVED WAS CAUSED DURING SCREW INSERTION/REMOVAL AND WORN AREAS INDICATE HIGH/PERMANENT LOAD BEING APPLIED TO THE NAIL. LAG SCREW OF U-BLADE SET: THE DAMAGE OF THE SHAFT WAS IDENTIFIED AS COLD SETS, WHICH WERE CAUSED DUE TO HIGH RESPECTIVELY PERMANENT LOAD BEARING. THE MARK AT THE EDGE OF THE FLUTE INDICATES THAT THE SET SCREW HAS BEEN INSERTED AS INTENDED TO ENSURE LOCKING OF THE LAG SCREW AGAINST ROTATION AND MIGRATION. LOCKING SCREWS Ø5X37,5MM: DAMAGE OBSERVED INDICATES HIGH/PERMANENT LOAD APPLICATION. GENERAL TECHNICAL ASPECTS: THE BROKEN IMPLANTS ARE TEMPORARY IMPLANTS WHICH INEVITABLY WILL BE SUBJECT OF A FATIGUE FRACTURE IF THE STRESSES ON THE IMPLANT ARE TOO HIGH OR NOT CONSIDERABLY REDUCED DURING THE PERIOD OF IMPLANTATION. THIS COULD BE DESCRIBED AS A RACE BETWEEN BONY CONSOLIDATION / FRACTURE HEALING AND IMPLANT BREAKAGE. IF FRACTURE HEALING IS INSUFFICIENT MECHANICAL DAMAGE OF A LOAD-BEARING OR LOAD-SHARING DEVICE IS MORE LIKELY. GENERALLY THE RISK OF A BREAKAGE WILL INCREASE WITH THE INCREASE OF LOAD CYCLES AND LOAD LEVEL. FINAL CONCLUSION: THE NAIL BROKE AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 6 MONTHS. INFORMATION ABOUT BONE HEALING WAS NOT PROVIDED. NEVERTHELESS WITH REGARD TO THE LONG IMPLANTATION PERIOD IT CAN BE CONCLUDED THAT THE LEVEL OF STRESS, WHICH DID NOT REDUCE DURING THE PERIOD OF IMPLANTATION CONTRIBUTED SIGNIFICANTLY TO THE BREAKAGE OF THE IMPLANT. ADDITIONALLY AN INTRAOPERATIVE DAMAGE OF THE GAMMA NAIL CAUSED BY A DEVIATED STEP DRILL RESULTING IN SIGNIFICANT WEAKENING OF THE GAMMA NAIL IN THE AREA OF THE LAG SCREW THRU HOLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY WITH THE G3 LONG NAIL. ON (B)(6), THE SURGEON CONFIRMED WITH X-RAY THAT HE FOUND THE NAIL TO BE BROKEN. THEREFORE, THE PATIENT UNDERWENT THE REVISION SURGERY BY THE PLATE ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY WITH THE G3 LONG NAIL. ON (B)(6), THE SURGEON CONFIRMED WITH X-RAY THAT HE FOUND THE NAIL TO BE BROKEN. THEREFORE, THE PATIENT UNDERWENT THE REVISION SURGERY BY THE PLATE ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283951 LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K878359

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention