BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO TS MOD. TIB. TRAY

    MDR report key: 7309198 · Received March 2, 2018

    Report

    Report Number
    0002249697-2018-00602
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 1, 2018
    Report Date
    April 4, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    UDI-DI
    07613327029284
    PMA / PMN Number
    K994128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE EVALUATED BY MFG. AN EVENT REGARDING UNLOCKING THE SCREW INVOLVING A SCORPIO TIBIAL BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: A FUNCTIONAL INSPECTION WAS CONDUCTED WITH AN SME, OPERATIONS ENGINEER AND TECHNICAL SERVICES. DRAWING CD-77-4003-AT SCORPIO TOTAL STABILIZER TOTAL KNEE TIBIAL TRAY #3-13 REV C NOTED IN NUMBER 2 THREAD PLUG (76-0001) MUST BE ASSEMBLED WITH 25-50 IN-LB OF TORQUE. A MANUAL TORQUE WRENCH PROTO 39825A WAS USED TO DETERMINE IF THE SCREW AT THE BOTTOM OF THE BASEPLATE IS WITHIN TOLERANCE. THE MANUAL TORQUE WRENCH WAS ABLE TO REMOVE THE SCREW WITH 35 IN-LB OF TORQUE WHICH IS WITHIN THE SPECIFIED TOLERANCE. A MATERIAL ANALYSIS WAS CONDUCTED BY A MATERIAL ANALYSIS ENGINEER AND STATED THAT ¿DAMAGE OBSERVED ON THREADS OF BOTH COMPONENTS. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED.¿ MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED BECAUSE NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE REPORTED EVENT OF ¿THE SURGEON COULDN¿T UNSCREW THE LOCKING SCREW ON THE SCORPIO TS TIBIAL TRAY¿ WAS NOT CONFIRMED BASED ON A FUNCTIONAL TEST CONDUCTED WITH THE RETURNED DEVICE AND AN OPERATIONS ENGINEER SME. THE FUNCTIONAL TEST RESULTED THAT THE DEVICE SCREW WAS WITHIN SPECIFICATION OF THE NOTED TOLERANCE ON THE DRAWING WHICH WAS BETWEEN 25-50 IN LB. THE ACTUAL REMOVAL TOLERANCE WITH A MANUAL TORQUE WRENCH WAS 35 IN LB. A MATERIAL ANALYSIS ENGINEER DID OBSERVE DAMAGES ON BOTH THREADED COMPONENTS BUT THERE WAS NO MANUFACTURING DISCREPANCIES OBSERVED ON THE SURFACES EXAMINED.

    Description of Event or Problem · 1

    THE SURGEON COULDN'T UNSCREW THE LOCKING SCREW ON THE SCORPIO TS TIBIAL TRAY FOR USING STEM EXTENSION, DURING THE SURGERY. SO, THE SURGEON CHANGED TO ANOTHER SCORPIO TS TIBIAL TRAY W/ DIFFERENT LOT NUMBER FOR SURGERY CLOSING. THERE WAS 5 ~ 10 MIN. DELAY OF SURGERY, DUE TO THE PROBLEM. LEFT KNEE.

    Description of Event or Problem · 1

    THE SURGEON COULDN'T UNSCREW THE LOCKING SCREW ON THE SCORPIO TS TIBIAL TRAY FOR USING STEM EXTENSION, DURING THE SURGERY. SO, THE SURGEON CHANGED TO ANOTHER SCORPIO TS TIBIAL TRAY W/ DIFFERENT LOT NUMBER FOR SURGERY CLOSING. THERE WAS 5 ~ 10 MIN. DELAY OF SURGERY, DUE TO THE PROBLEM. LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152113 SCORPIO TS MOD. TIB. TRAY PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH 5V868TA 07613327029284

    Patients

    Seq Age Sex Outcome Treatment
    1 Other