BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW VARIAX FULL THREAD 2.7MM / L18MM

    MDR report key: 6041895 · Received October 19, 2016

    Report

    Report Number
    0008031020-2016-00516
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 21, 2016
    Report Date
    March 15, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K101056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    DEVICE NOT RETURNED. THE REPORTED EVENT THAT A LOCKING SCREW VARIAX FULL THREAD 2.7MM / L18MM COULD NOT LOCK TO A PLATE COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THESE ARE SOME OF THE POSSIBLE CAUSES: - CARELESSNESS - UNEXPERIENCED OR UNTRAINED MEDICAL PERSON - INSUFFICIENT TIGHTENING TORQUE APPLIED - TOO HIGH TORQUE APPLIED - THE DEVICE HAD BEEN ALREADY USED ONCE - THE DEVICE WAS DAMAGED DURING STORAGE OR TRANSPORTATION. 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 THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. THE INSTRUCTION FOR USE (V15052 REV C NON-ACTIVE IMPLANT AXSOS RRD) WAS REVIEWED: ''ENSURE THAT YOU ARE FAMILIAR WITH THE INTENDED USES, INDICATIONS/CONTRAINDICATIONS, COMPATIBILITY AND CORRECT HANDLING OF THE IMPLANT, WHICH ARE DESCRIBED IN THE OPERATIVE TECHNIQUE MANUAL FOR THE PRODUCT SYSTEM. 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. PRE-OPERATIVE ¿ THE IMPLANT IS FOR SINGLE USE ONLY. ¿ INSPECTION IS RECOMMENDED PRIOR TO SURGERY TO DETERMINE IF IMPLANTS HAVE BEEN DAMAGED DURING STORAGE. INTRA-OPERATIVE ¿ AVOID SURFACE DAMAGE OF IMPLANTS. ¿ DISCARD ALL DAMAGED OR MISHANDLED IMPLANTS. ¿ DURING THE COURSE OF THE OPERATION, REPEATEDLY CHECK TO ENSURE THAT THE CONNECTION BETWEEN THE IMPLANT AND THE INSTRUMENT, OR BETWEEN THE INSTRUMENTS, REQUIRED FOR PRECISE POSITIONING AND FIXING IS SECURE.''

    Description of Event or Problem · 1

    DURING VARIAX CLAVICLE SURGERY, THE SURGEON ASSEMBLED THE AIMING BLOCK TO THE PLATE AND DRILLED. THE SURGEON TRIED TO INSERT THE SCREW BUT COULDN'T LOCKED THE SCREW TO THE PLATE. THE SURGEON REMOVED THE AIMING BLOCK AND DRILLED ANOTHER DIRECTION. THE RESULT WAS SAME. THE SURGEON CHANGED THE SCREW TO BRAND NEW SCREW(SAME SIZE).

    Description of Event or Problem · 1

    DURING VARIAX CLAVICLE SURGERY, THE SURGEON ASSEMBLED THE AIMING BLOCK TO THE PLATE AND DRILLED. THE SURGEON TRIED TO INSERT THE SCREW BUT COULDN'T LOCKED THE SCREW TO THE PLATE. THE SURGEON REMOVED THE AIMING BLOCK AND DRILLED ANOTHER DIRECTION. THE RESULT WAS SAME. THE SURGEON CHANGED THE SCREW TO BRAND NEW SCREW(SAME SIZE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690484 LOCKING SCREW VARIAX FULL THREAD 2.7MM / L18MM PLATE, FIXATION, BONE HRS STRYKER GMBH J27366

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other