BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, T7 DIAM.2.3X18MM

    MDR report key: 6926739 · Received October 7, 2017

    Report

    Report Number
    0008010177-2017-00254
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Date of Event
    September 15, 2017
    Report Date
    December 27, 2017
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K080667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE MODE COULD BE CONFIRMED: THE RETURNED SCREW EXHIBITED A DIAGNOL BREAK WITH A ROUGH SURFACE, WHICH IS TYPICAL FOR A BRITTLE FAILURE DUE TO A SUDDEN TORSIONAL LOAD. A POSSIBLE REASON FOR BREAKAGE IS THUS THE APPLICATION OF EXCESSIVE FORCE (TORQUE). FURTHERMORE IT WAS REPORTED THAT THAT A RIGHT PLATE WAS IMPLANTED ON A LEFT WRIST. THE PROVIDED X-RAY IMAGE SHOWS THAT THE ANGLE OF THE REMAINING PART OF THE BROKEN SCREW IS NOT IN THE ALLOWED 30° CONE REQUIRED FOR LOCKING. THE ANGLE IS MUCH LARGER THAN THE ALLOWED 15°. IT COULD BE THAT LARGE ANGLE IS RELATED TO THE USAGE OF THE WRONG PLATE, I.E. A PLATE THAT DID NOT FIT NICELY. THE OPTECH "VAX-ST-1-EN REV 0 VARIAX DR OPTECH" STATES: "SMARTLOCK POLYAXIAL DRILL GUIDE (56-01250) ALLOWS FOR ±15 DEGREES OF CUSTOM ANGULATION AND MAY BE USED FOR MORE COMPLEX FRACTURES. A LIP ON THE DRILL SLEEVE WILL ENGAGE AND ALLOW TOGGLING IN THE HOLE. THE RANGE IN WHICH THE DRILL GUIDE TOGGLES WILL CREATE A 30-DEGREE CONE AND EVERY ANGLE IN THIS RANGE WILL BE A LOCKING POSITION. THIS MAY ALLOW THE SURGEON TO AIM WHERE THE SCREW/PEG SHOULD BE PLACED. ALSO, DEPENDING ON THE PLACEMENT OF THE PLATE, THERE MAY BE A NEED TO ANGLE A SCREW/PEG OUT OF THE FRACTURE LINE. NOTE: USING ONE OF THE PROVIDED DRILL GUIDES FOR SCREW HOLE PREPARATION IS MANDATORY. NOT USING A DRILL GUIDE MAY LEAD TO DRILLING OUT OF SPECIFIED LOCKING RANGE AND COMPROMISE THE LOCKING CAPABILITIES." [ORIGINAL STATEMENTS]. THE IFU 90-01960 REV AB, 07-2017 WAS REVIEWED: "THE CORRECT SELECTION OF THE PRODUCT IS EXTREMELY IMPORTANT. THE PRODUCT SHOULD BE USED IN THE CORRECT ANATOMIC LOCATION, CONSISTENT WITH ACCEPTED STANDARDS FOR INTERNAL FIXATION. FAILURE TO USE THE APPROPRIATE PRODUCT FOR THE APPLICATION MAY RESULT IN A PREMATURE CLINICAL FAILURE. FAILURE TO USE THE PROPER COMPONENT TO MAINTAIN ADEQUATE BLOOD SUPPLY AND PROVIDE RIGID FIXATION MAY RESULT IN LOOSENING, BENDING OR FRACTURING OF THE PRODUCT AND/OR BONE. " "PLACEMENT OF ALL LOCKING SCREWS REQUIRES THE USE OF THE LOCKING DRILL GUIDE (62-51723) TO ENSURE PROPER SCREW PLACEMENT. IF A DRILL GUIDE IS NOT USED, THE SCREW MAY NOT LOCK INTO THE PLATE. " IF PLACING A BONE SCREW IN A LOCKING HOLE IT REQUIRES THE USE OF THE LOCKING DRILL GUIDE (62-51723) TO ENSURE PROPER SCREW PLACEMENT. THE ANGLE OF THE INSERTED SCREW MAY NOT EXCEED 10°." "SCREWS SHOULD NOT BE OVER-TIGHTENED DURING INSERTION. EXCESSIVE OVER-TIGHTENING WILL COMPROMISE THE INTEGRITY OF THE SCREW HEAD, RESULT IN POSSIBLE SCREW BREAKAGE, AND LEAD TO LOSS OF FRICTION FIT PERFORMANCE." [ORIGINAL STATEMENTS]. POSSIBLE ROOT CAUSES AMONG OTHERS ARE USING THE WRONG PLATE, NOT USING DRILL GUIDES FOR HOLE PREPARATION, APPLYING TOO HIGH TORQUES. IN SUMMARY, WE CONCLUDE THAT THE REPORTED FAILURE IS MOSTLIKELY A USER ERROR AND NOT A PRODUCT FAILURE. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    A DISTAL RADIUS VARIAX PLATE WAS FIXED TO A PATIENT. THE MOST PROXIMAL SCREW WENT SKEW THROUGH THE PLATE AND WAS THEN SNAPPED AGAINST THE FURTHEST CORTEX. THE HEAD OF THE SCREW COULD BE REMOVED, THE OTHER PART IS STILL IN THE PATIENT'S BONE. THERE WAS A SURGICAL DELAY OF 15 MINUTES. THE SALES REP INDICATED THAT JUST ONE SCREW BROKE AND THE OTHER SCREW ALSO BENT FOR THE SECOND CORTEX. THE SURGEON DOES NOT ANTICIPATES ANY LASTING CONSEQUENCES. THE REP REPORTED THAT THE SURGEON USED A RIGHT PLATE ON A LEFT WRIST

    Description of Event or Problem · 1

    A DISTAL RADIUS VARIAX PLATE WAS FIXED TO A PATIENT. THE MOST PROXIMAL SCREW WENT SKEW THROUGH THE PLATE AND WAS THEN SNAPPED AGAINST THE FURTHEST CORTEX. THE HEAD OF THE SCREW COULD BE REMOVED, THE OTHER PART IS STILL IN THE PATIENT'S BONE. THERE WAS A SURGICAL DELAY OF 15 MINUTES. THE SALES REP INDICATED THAT JUST ONE SCREW BROKE AND THE OTHER SCREW ALSO BENT FOR THE SECOND CORTEX. THE SURGEON DOES NOT ANTICIPATES ANY LASTING CONSEQUENCES. THE REP REPORTED THAT THE SURGEON USED A RIGHT PLATE ON A LEFT WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706602 LOCKING SCREW, T7 DIAM.2.3X18MM PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other