BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X300MM X 125°

    MDR report key: 4142496 · Received October 6, 2014

    Report

    Report Number
    0009610622-2014-00537
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERRING TO PRODUCT INQUIRY THE LONG NAIL KIT R2.0, TI, LEFT GAMMA3 Ø11X300MM X 125° IS STATED TO BE THE PRIMARY PRODUCT. THE LAG SCREW AND THE LOCKING SCREW 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 REPORTED 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, WHEREAS IT HAS TO BE ASCERTAINED THAT THE DATE OF IMPLANTATION IS UNKNOWN AND THUS, THE ENTIRE IMPLANTATION DURATION. DRILL MARKS ARE FOUND AT THE LATERAL EDGE OF THE PROXIMAL BORE, IN PARTICULAR AT THE INSIDE OF THE ANTERIOR WEB AT LATERAL. SAME TRACES ARE VISIBLE AT THE DISTAL PORTION OF THE BORE IN THE AREA OF THE MEDIAL EDGE. THE DRILL MARKS ARE PARTLY COVERED BY CONSIDERABLE FRICTION MARKS, WHICH WERE GENERATED BY THE LAG SCREW AFTER THE NAIL BREAKAGE. THE DRILL MARKS WERE GENERATED BY A DEVIATED LAG SCREW STEP DRILL WHICH MOST LIKELY HAD CREATED THE STARTING POINT OF THE FRACTURE (NOTCHING EFFECT) AT THE LATERAL EDGE OF THE ANTERIOR WEB. THE SET SCREW SHOWS A FLATTENING BESIDE THE VERY TIP, WHICH INDICATES THAT THE SCREW HAD NOT BEEN INSERTED UP TO THE INTENDED POSITION RESP. THAT THE VERY TIP DID NOT REACH THE GROUND OF THE LAG SCREW GROOVE DURING THE FIRST STEP OF THE POSITIONING PROCESS. THIS IS SUPPORTED BY MISSING TRACES OF THE SET SCREW ON THE GROUND OF THE SUPERIOR LAG SCREW GROOVE. MATERIAL DEFORMATION (FRICTION MARKS) 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 MORE THAN PARTIAL WEIGHT BEARING. THE COUNTERPARTS WERE FOUND ON THE LAG SCREW IN THE AREAS WITH FRICTION MARKS WHERE THE EDGES OF THE SLIDING GROOVES HAD BECOME WORN. THE AFFECTED NAIL 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 AND BY SCIENTIFIC ANALYSIS CONFIRMED PERIOD (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. BASED ON THE ABOVE THE NAIL BREAKAGE IS NOT LINKED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER CONSIDERED USER RELATED; MOST LIKELY THE CONSIDERABLE INTRAOPERATIVE DAMAGE OF THE GAMMA3 NAIL CAUSED BY A DEVIATED STEP DRILL, HAD LED TO A SIGNIFICANT WEAKENING OF THE NAIL IN THE AREA OF THE LAG SCREW THRU HOLE AND WAS CONTRIBUTED BY PROLONGED OVERLOAD BY THE PATIENT, FOLLOWED BY THE FATIGUE FRACTURE AFTER AN UNKNOWN IMPLANTATION DURATION. NO NON-CONFORMITY WAS IDENTIFIED.

    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 PATIENT HAD REVISION OF LEFT HIP. SALES REP REPORTED GAMMA NAIL BROKE AT THE JUNCTION OF THE LAG SCREW. REP REPORTED, "PER PHYSICIAN, PATIENT WALKED TO MAILBOX AND FELT NAIL/HIP "POP". PATIENT WAS REVISED TO A GAMMA 3 NAIL 11X 320 X 120 DEG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION OF LEFT HIP. SALES REP REPORTED GAMMA NAIL BROKE AT THE JUNCTION OF THE LAG SCREW. REP REPORTED, "PER PHYSICIAN, PATIENT WALKED TO MAILBOX AND FELT NAIL/HIP "POP". PATIENT WAS REVISED TO A GAMMA 3 NAIL 11X 320 X 120 DEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624687 LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X300MM X 125° INTRAMEDULLARY FIXATION ROD HSB STRYKER TRAUMA KIEL K131238

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention