BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEPDRILL FOR LAG SCREW T2 RECON

    MDR report key: 6146591 · Received December 5, 2016

    Report

    Report Number
    0009610622-2016-00596
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 10, 2016
    Report Date
    March 23, 2017
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED THE REPORTED STEPDRILL FOR LAG SCREW T2 RECON TO BE THE PRIMARY PRODUCT. THE OTHER ITEMS MENTIONED ARE CONSIDERED CONCOMITANT PRODUCTS. REVIEW OF THE INSPECTION RECORDS FOR THE RETURNED STEP DRILL REVEALED NO DISCREPANCIES; THE DEVICE WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THE 1ST STEP OF THE DRILL IS COMPLETELY SHEARED OFF. THUS, INTENDED FUNCTION IS NO LONGER GIVEN. THE FRONT CUTTING EDGES OF THE 1ST STEP ARE SIGNIFICANTLY WORN / DEFORMED AND SHOW TRACES OF HARD USE. THE RIM AT THE BORE IS BEADED BY HARD CONTACT WITH A K-WIRE DURING DRILLING. THE APPEARANCE OF DAMAGE AT THE FRONT CUTTING EDGES OF THE BROKEN OFF 1ST STEP CLEARLY INDICATES THAT THE CUTTING PERFORMANCE WAS SIGNIFICANTLY DECREASED. A PRE-SURGICAL FUNCTION TEST WAS PERFORMED ON THE STEP DRILL AND K-WIRES RETURNED. THE TEST SET UP WAS COMPLETED WITH THE RETURNED NAIL FROM THE SAME CASE (PI-1359144) AND SAMPLE DEVICES (NAIL HOLDING SCREW, TARGET DEVICE T2 RECON INCL. KNOB, DRILL SLEEVES, TISSUE PROTECTION SLEEVES, K-WIRE SLEEVES). RESULT: THE RETURNED STEP DRILL (WITHOUT THE BROKEN OFF PORTION) PASSED THE PROXIMAL DRILL HOLES WITHOUT CONTACT TO THE NAIL. BOTH RECEIVED K-WIRES PASSED THE PROXIMAL DRILL HOLES CENTRALLY (RECON MODE) WITHOUT CONTACT TO THE NAIL. FOLLOWING THE APPROPRIATE STEPS IN THE ¿T2 RECON NAILING SYSTEM R1.5 OPERATIVE TECHNIQUE¿ THE REPORTED EVENT AND THE RESULTING DAMAGE AT THE STEP DRILL AND NAIL COULD NOT BE REPRODUCED. THE FUNCTIONAL INSPECTION REVEALED NO DISCREPANCIES REGARDING THE RETURNED K-WIRES, WHICH ARE STILL FUNCTIONAL. DURING THE FUNCTIONAL CHECK OF THE CORRESPONDING PI-1359144 (PHASE 3 INVESTIGATION # (B)(4)) DRILLING WITH A SAMPLE CANNULATED STEP DRILL OVER K-WIRES WAS SIMULATED WITHOUT USING THE DRILL SLEEVE; THE SAMPLE CANNULATED STEP DRILL MISSED THE PROXIMAL DRILL HOLES (RECON MODE) AND CONTACTED THE NAIL AT THE OUTER SURFACE. THE PRESENT DAMAGE PATTERN (SIGNIFICANT DRILL MARKS AT THE LATERAL SURFACE OF THE NAIL) COULD EXACTLY BE REPRODUCED. BASED ON THE ABOVE, MASSIVE BENDING FORCES DURING DRILLING AT THE OUTER SURFACE OF THE NAIL MAY HAVE LED TO THE FORCED FRACTURE AT THE TRANSITION FROM THE 1ST TO THE 2ND STEP OF THE DRILL. THE EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED BUT THE APPEARANCE AND EXTENT OF DAMAGE INDICATE THAT THE ROOT CAUSE OF THE REPORTED EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE BUT IS RATHER RELATED TO USER ERROR. TAKING INTO CONSIDERATION THAT THE SALES REP HAS CONFIRMED THE CORRESPONDING TARGET DEVICE (PI-1359144 / SAME SURGERY) TO BE FULLY FUNCTIONAL IT CAN BE CONCLUDED THAT THE EVENT WAS MAINLY BASED IN A SUB-OPTIMAL INTRA-OPERATIVE PROCEDURE, WHICH IS SUPPORTED BY THE CONSIDERABLE DRILL MARKS FOUND AT THE LATERAL SURFACE OF THE CORRESPONDING NAIL NEXT TO THE PROXIMAL BORES (ANTERIOR). REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. 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

    THE STRYKER CLINICAL SUPPORT SPECIALIST REPORTED THAT DURING A FEMORAL NAILING PROCEDURE, THE SURGEON MADE A SUCCESSFUL ENTRY WITH THE NAIL AND THE GUIDE. DURING THIS PROCEDURE, THE GUIDE WIRES ATTACH TO THE AIMING JIG TO GIVE A POSITION TO PASS A REAMER OVER THE WIRE TO MAKE A TRACK FOR THE LOCKING SCREW. THE FIRST PASS FOR THE FIRST LOCKING SCREW WAS UNDERTAKEN SUCCESSFULLY. WHEN THE REAMER WAS PASSED OVER THE SECOND WIRE, THE TIP OF THE CANNULATED REAMER SNAPPED OFF AND WAS LEFT ON THE GUIDE WIRE. THE SURGEON WITHDREW THE BROKEN REAMER TIP AND THERE WAS NO METAL LEFT IN THE PATIENT. LESS THAN A 30 MINUTE DELAY TO SURGERY. THE CASE WAS COMPLETED USING A SINGLE USE STERILE REAMER.

    Description of Event or Problem · 1

    THE STRYKER CLINICAL SUPPORT SPECIALIST REPORTED THAT DURING A FEMORAL NAILING PROCEDURE, THE SURGEON MADE A SUCCESSFUL ENTRY WITH THE NAIL AND THE GUIDE. DURING THIS PROCEDURE, THE GUIDE WIRES ATTACH TO THE AIMING JIG TO GIVE A POSITION TO PASS A REAMER OVER THE WIRE TO MAKE A TRACK FOR THE LOCKING SCREW. THE FIRST PASS FOR THE FIRST LOCKING SCREW WAS UNDERTAKEN SUCCESSFULLY. WHEN THE REAMER WAS PASSED OVER THE SECOND WIRE, THE TIP OF THE CANNULATED REAMER SNAPPED OFF AND WAS LEFT ON THE GUIDE WIRE. THE SURGEON WITHDREW THE BROKEN REAMER TIP AND THERE WAS NO METAL LEFT IN THE PATIENT. LESS THAN A 30 MINUTE DELAY TO SURGERY. THE CASE WAS COMPLETED USING A SINGLE USE STERILE REAMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796471 STEPDRILL FOR LAG SCREW T2 RECON ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KU93568

    Patients

    Seq Age Sex Outcome Treatment
    1 Other