BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM

    MDR report key: 5473096 · Received March 2, 2016

    Report

    Report Number
    0008031020-2016-00091
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Date of Event
    February 4, 2016
    Report Date
    February 4, 2016
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K132502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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

    THE REPORTED INCIDENT THAT LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM WAS ALLEGED OF ISSUE S-35 (NO LOCKING EFFECT) COULD BE CONFIRMED, SINCE THE RETURNED DEVICE MATCHED THE REPORTED FAILURE. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE LOCKING PART OF THE SCREW THREAD WAS MOST LIKELY STRIPPED DURING THE USAGE OF THE SCREW, PREVENTING THE LOCKING MECHANISM TO FUNCTION PROPERLY. THE DEVICE INSPECTION REVEALED THAT THERE IS A PART OF THE THREAD MISSING IN THE THREADED LOCKING PART OF THE SCREW. THIS LEAD TO THE CREATION OF A SLOPE IN THE THREAD PREVENTING THE SCREW TO FULLY ENGAGE IN THE PLATE, AND SO, IT PREVENTED THE LOCKING MECHANISM TO WORK. THIS IS A SINGLE USE DEVICE, HOWEVER IT CANNOT BE EXCLUDED THAT THE DAMAGES TO THE THREAD OCCURRED IN A PREVIOUS USAGE OF THIS DEVICE. NOTE, AS STATED IN THE IFU (V15013): ¿WARNINGS SINGLE USE DEVICES CANNOT BE REUSED, AS THEY ARE NOT DESIGNED TO PERFORM AS INTENDED AFTER THE FIRST USAGE. CHANGES IN MECHANICAL, PHYSICAL OR CHEMICAL CHARACTERISTICS INTRODUCED UNDER CONDITIONS OF REPEATED USE, CLEANING AND RE-STERILIZATION MAY COMPROMISE THE INTEGRITY OF THE DESIGN AND/OR MATERIALS LEADING TO DIMINISHED SAFETY, PERFORMANCE AND/OR COMPLIANCE WITH RELEVANT SPECIFICATIONS. PLEASE REFER TO THE DEVICE LABEL TO IDENTIFY SINGLE OR MULTIPLE USE AND/OR CLEANING AND RE-STERILIZATION RELEASE.¿ ADDITIONALLY, NOTE THAT THE INSERTION ANGLE OF THE LOCKING SCREW SHOULD BE A CONE WITH 30° ANGLE. ANY EXCESSES IN THE ANGULATION MIGHT LEAD TO THE NON FUNCTION OF THE LOCKING MECHANISM AND EVEN THE DAMAGE OF THE THREAD OF THE SCREW. NOTE, AS STATED IN THE OPERATIVE TECHNIQUE ((B)(4)): ¿SMARTLOCK LOCKING TECHNOLOGY- THE POLYAXIAL LOCKING TECHNOLOGY WORKS BY USING TWO DIFFERENT GRADES OF TITANIUM. LOCKING SCREWS ARE MADE OF TITANIUM ALLOY ((B)(4)) WHICH IS STRONGER THAN THE PURE TITANIUM PLATE. WHEN A SCREW IS DRIVEN INTO A PLATE HOLE, THE LOCKING THREADS ON THE UNDERSIDE OF THE SCREW HEAD ENGAGE THE CIRCULAR ¿LIP¿ IN THE HOLE. THIS TECHNOLOGY ALLOWS THE SURGEON TO AIM AND LOCK THE SCREW WITHIN A 30° CONE.¿ A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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.

    Description of Event or Problem · 1

    A 3.5MM 12MM LOCKING SCREW WAS SCREWED INTO A WRIST FUSION PLATE. THE LOCKING SCREW DID NOT LOCK INTO THE PLATE. 3 MINUTE DELAY TO SWITCH SCREW OUT FOR ANOTHER ONE. SALES REP REPORTED EVENT OCCURRED DURING PRIMARY SURGERY.

    Description of Event or Problem · 1

    THE 3.5MM 12MM LOCKING SCREW WAS SCREWED INTO A WRIST FUSION PLATE. THE LOCKING SCREW DID NOT LOCK INTO THE PLATE. THREE MINUTE DELAY TO SWITCH SCREW OUT FOR ANOTHER ONE. SALES REP REPORTED EVENT OCCURRED DURING PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131391 LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM PLATE, FIXATION, BONE HRS STRYKER GMBH J13290

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other