BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM

    MDR report key: 16362823 · Received February 13, 2023

    Report

    Report Number
    3010667733-2023-00069
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    January 18, 2023
    Report Date
    May 2, 2023
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    UDI-DI
    07613327068689
    PMA / PMN Number
    K180500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D1, D2A, D2B, D4 (CATALOG#, LOT#), GTIN, G1, G4 (510(K)), H3, H6 (METHOD CODE). THE REPORTED NON-UNION CAN BE CONFIRMED BASED ON THE PROVIDED OPERATION REPORT OF THE REVISION SURGERY. THE DEVICE INSPECTION REVEALED THE FOLLOWING: ONE (1) PLATE TOGETHER WITH SEVEN (7) SCREWS WAS RETURNED FOR EVALUATION. THE PLATE IS BROKEN APART AND DOES BELONG TO THE LEGACY STRYKER VARIAX 2 FOOT SYSTEM. THREE (3) OF THE RETURNED SCREWS BELONG TO THE VARIAX 2 SYSTEM. THE OTHER FOUR (4) SCREW BELONG MOST LIKELY TO THE LEGACY WRIGHT MEDICAL CANNULATED SCREW SYSTEM (CSS). THE EVALUATION OF THESE DEVICES WILL BE PERFORMED UNDER THE COMPLAINTS 3216512, 3216513, 3223765 AND 3223766. THE VISUAL INSPECTION HAS SHOWN THAT THE RETURNED 16MM VARIAX LOCKING SCREW IS IN A USED CONDITION, THE HEAD AND AS WELL THE THREAD FLANKS HAVE CLEARLY VISIBLE WEAR MARKS. ALSO THE LOCKING THREAD IS SLIGHTLY WORN, WHICH INDICATES THAT THE SCREW WAS LOCKED IN THE PLATE AS REQUIRED. AFTERWARDS IT CANNOT BE DEFINED ANYMORE IF THESE DAMAGES OCCURRED DURING IMPLANTATION, IN-SITU OR DURING EXTRACTION. OTHERWISE IS THE SCREW IN A GOOD CONDITION AND THERE IS NO INDICATION THAT ANY ISSUE AT THE SCREW DID CONTRIBUTE TO THE REPORTED NON-UNION. 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. NO PRODUCT RELATED ISSUE COULD BE DETECTED. THERE WAS NO ADDITIONAL INFORMATION ABOUT THE EVENT PROVIDED, IT IS UNKNOWN HOW LONG THE IMPLANTS WERE IMPLANTED, NO X-RAYS AND NO INFORMATION ABOUT THE PATIENT HISTORY/ACTIVITY WAS PROVIDED. IN ADDITION, IT IS UNKNOWN HOW THE RETURNED IMPLANTS FROM DIFFERENT SYSTEMS ARE RELATED TO EACH OTHER. THEREFORE THE ROOT CAUSE OF THE REPORTED NON-UNION CANNOT BE DEFINED. DURING THE INVESTIGATION NO INDICATION COULD BE DETECTED THAT THE RETURNED SCREWS DID CONTRIBUTE TO THE REPORTED NON-UNION AND THERE WAS NO ALLEGATION AGAINST THE SCREWS, E.G. LOOSENING, REPORTED. THESE FINDINGS SPEAK AGAINST A SCREW RELATED ISSUE. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN THE RIGHT FOOT AND IN THE IMPLANT. THE PATIENT HAD HARDWARE REMOVED DUE TO MECHANICAL FAILURE/MALFUNCTION OF FUSION( RIGHT FOOT). THE INITIAL DIAGNOSIS WAS PSEUDARTHROSIS AFTER FUSION OR ARTHRODESIS. THE PRE-OPERATIVE DIAGNOSIS WAS RIGHT HALLUX LIMITUS WITH NON-UNION. NON-UNION HALLUX INTERPHALANGEAL JOINT FUSION. THE PATIENT UNDERWENT REVISION RIGHT FIRST METATARSAL PHALANGEAL JOINT FUSION. RIGHT FOOT HARDWARE REMOVAL. RIGHT HALLUX ARTHROPLASTY. CALCANEAL BONE GRAFT HARVESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN THE RIGHT FOOT AND IN THE IMPLANT. THE PATIENT HAD HARDWARE REMOVED DUE TO MECHANICAL FAILURE/MALFUNCTION OF FUSION( RIGHT FOOT). THE INITIAL DIAGNOSIS WAS PSEUDARTHROSIS AFTER FUSION OR ARTHRODESIS. THE PRE-OPERATIVE DIAGNOSIS WAS RIGHT HALLUX LIMITUS WITH NON-UNION. NON-UNION HALLUX INTERPHALANGEAL JOINT FUSION. THE PATIENT UNDERWENT REVISION RIGHT FIRST METATARSAL PHALANGEAL JOINT FUSION. RIGHT FOOT HARDWARE REMOVAL. RIGHT HALLUX ARTHROPLASTY. CALCANEAL BONE GRAFT HARVESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387155 LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM SCREW, FIXATION, BONE HWC STRYKER GMBH 58803518 1000476057 07613327068689

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention