BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW AXSOS 3 TI 4.0MM / L30MM

    MDR report key: 6714763 · Received July 14, 2017

    Report

    Report Number
    0008031020-2017-00433
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 26, 2017
    Report Date
    October 6, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K123964
    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

    THE REPORTED EVENT THAT LOCKING SCREW AXSOS 3 TI 4.0MM / L30MM WAS ALLEGED OF ISSUE S-14 (HEAD DAMAGED) COULD BE CONFIRMED, SINCE THE RETURNED DEVICE MATCHED THE REPORTED FAILURE MODE. THE DEVICE WAS RETURNED FOR EVALUATION AND THE INSPECTION REVEALED SEVERAL SCRATCHES AND DENT MARKS ON THE HEAD OF THE SCREW. ALSO, DISCOLORATION OF THE SCREW IS CLEARLY EVIDENT ON THE SURFACE OF THE SCREW. THIS COULD BE DUE TO REPEATED CLEANING AND STERILIZATION CYCLES AND THE USE OF AN AGGRESSIVE CLEANING AGENT. THE GIVEN IMPLANT WAS DELIVERED STERILE. REPROCESSING, CLEANING AND RE STERILIZATION COMPROMISED THE INTEGRITY OF THE DESIGN AND/OR MATERIAL LEADING TO DIMINISHED SAFETY, PERFORMANCE AND/OR COMPLIANCE WITH RELEVANT SPECIFICATIONS. SIGNS OF SEVERE DAMAGE ARE VISIBLE DUE TO HIGH AXIAL AND TORSIONAL FORCES DURING SCREW INSERTION. THE DAMAGE AT THE SCREW HEAD IS DUE TO A MISUSE OF THE LOCKING SCREW WITH THE POWER TOOL. SCREWS SHOULD BE TIGHTENED TO A MAXIMUM TORQUE OF 4.0NM. BECAUSE THE TORQUE APPLIED WENT BEYOND THE YIELD STRENGTH OF THE SCREW, IT LED TO THE REPORTED FAILURE. POWER CAN NEGATIVELY AFFECT SCREW INSERTION, IF USED IMPROPERLY, DAMAGING THE SCREW (SCREW JAMMING). THIS CAN LEAD TO SCREW HEADS BREAKING OR BEING STRIPPED. ALSO THE OPERATIVE TECHNIQUE INSTRUCTS CLEARLY THAT ¿IF INSERTING LOCKING SCREWS UNDER POWER, MAKE SURE TO USE A LOW SPEED TO AVOID DAMAGE TO THE SCREW/PLATE INTERFACE, AND PERFORM FINAL TIGHTENING BY HAND. BASED ON INVESTIGATION THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE IS MOST LIKELY CAUSED DUE TO FAILURE OF THE SURGEON TO FOLLOW THE INSTRUCTION AS PER THE OPERATIVE TECHNIQUE. THE OPERATIVE TECHNIQUE STATES THAT THE SURGEON IS NOT SUPPOSED TO USE A POWER TOOL UNTIL THE END, THE FINAL TIGHTENING OF LOCKING SCREWS SHOULD ALWAYS BE PERFORMED MANUALLY. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    TREATED FOR A DISTAL FRACTURE OF THE TIBIA AND FIBULA. ATTEMPTED TO INSERT THE LOCKING SCREW BY DRILL AFTER IMPLANTING A DISTAL SCREW AND A PROXIMAL SCREW . THE TIP OF THE DRIVER AND THE HEAD OF THE LOCKING SCREW WERE DAMAGED. THE SCREW COULD NOT BE PULLED OUT BY THE SCREWDRIVER BECAUSE THE HEAD OF THE SCREW WAS DAMAGED. THE TIP OF BROKEN SCREWDRIVER WAS REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    TREATED FOR A DISTAL FRACTURE OF THE TIBIA AND FIBULA. ATTEMPTED TO INSERT THE LOCKING SCREW BY DRILL AFTER IMPLANTING A DISTAL SCREW AND A PROXIMAL SCREW . THE TIP OF THE DRIVER AND THE HEAD OF THE LOCKING SCREW WERE DAMAGED. THE SCREW COULD NOT BE PULLED OUT BY THE SCREWDRIVER BECAUSE THE HEAD OF THE SCREW WAS DAMAGED. THE TIP OF BROKEN SCREWDRIVER WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495064 LOCKING SCREW AXSOS 3 TI 4.0MM / L30MM PLATE, FIXATION, BONE HRS STRYKER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other