BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 32MM

    MDR report key: 7121192 · Received December 15, 2017

    Report

    Report Number
    2939274-2017-50297
    Event Type
    Injury
    Date Received
    December 15, 2017
    Report Date
    November 15, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982210944
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT¿S IDENTIFIER: (B)(6). (B)(4). THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NO.: 412.210, LOT NO.:1983415, MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: 15.SEP.2008: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. THE 5.0MM TI LOCKING SCREW SELF TAPPING WITH T25 STARDRIVE RECESS 32MM IS AVAILABLE IN THE LESS INVASIVE STABILIZATION SYSTEM (LISS). THE SYSTEM ALLOWS PERCUTANEOUS PLATE INSERTION AND TARGETING OF SCREWS IN THE DISTAL FEMUR. THE RETURNED DEVICE WAS EXAMINED AND NO DEFECTS OR DEFICIENCIES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT OF PERIPROSTHETIC FRACTURE. WHETHER THE COMPLAINT CONDITION IS ABLE TO BE REPLICATED IS NOT APPLICABLE TO THIS COMPLAINT CONDITION. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE). THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. NO DIMENSIONAL ANALYSIS IS APPLICABLE AS THERE IS NO ALLEGATION AGAINST THE DEVICE. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL REVIEW, WAS PERFORMED FOR THE RETURNED DEVICE¿S LOT NUMBER AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION OF A TITANIUM DISTAL FEMUR LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE AND THIRTEEN (13) SCREWS TO AN UNKNOWN ZIMMER PLATE CONSTRUCT DUE TO A FRACTURE WHICH WAS SLIGHTLY DISTAL TO THE SYNTHES LISS FEMUR PLATE ON (B)(6) 2017. ONE (1) LISS PLATE ALONG WITH APPROXIMATELY THIRTEEN (13) UNKNOWN SCREWS WERE INITIALLY IMPLANTED ON AN UNKNOWN DATE A FEW YEARS AGO. BASED ON A PREVIOUSLY TAKEN X-RAY (UNAVAILABLE) TAKEN BEFORE THE REVISION SURGERY, THE PLATE AND SCREWS ALL SEEMED INTACT AND WERE FOUND INTACT DURING SURGERY. THE REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DELAY IN SURGERY DUE TO THREE (3) SYNTHES SCREWDRIVERS BREAKING WHILE REMOVING THE THREE (3) COLD WELDED / CROSS THREADED SCREWS THAT WERE STUCK TO THE PLATE. AFTER THE SCREWDRIVERS BROKE, THE SCREWS HAD TO BE CUT OUT WITH A BIG BURR. IT IS UNKNOWN IF THERE WERE ANY FRAGMENTS LEFT INSIDE THE PATIENT. THIS REPORT ADDRESSES THE POSTOPERATIVE REVISION DUE TO PATIENT¿S FRACTURE WHICH WAS SLIGHTLY DISTAL TO THE SYNTHES LISS FEMUR PLATE THE INTRAOPERATIVE ISSUE OF COLD WELDED / CROSS THREADED SCREWS THAT WERE STUCK TO THE PLATE. THE INTRAOPERATIVE ISSUE OF THREE (3) BROKEN SCREWDRIVERS AND THREE COLD WELDED / CROSS THREADED SCREWS THAT WERE STUCK TO THE PLATE HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW SELF-TAPPING WITH T25 STARDRIVE RECESS 32MM THIS IS REPORT 4 OF 11 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900902 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 32MM APPLIANCE,FIXATION,NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 412.210 1983415 10886982210944

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention