BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER T25

    MDR report key: 7117305 · Received December 14, 2017

    Report

    Report Number
    2939274-2017-50265
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 9, 2017
    Report Date
    November 15, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188557
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED COMPLAINT DESCRIPTION. CORRECTED DATA: CORRECTED COMPLAINT DESCRIPTION. CORRECTED CONCOMITANT DEVICES. 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 REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NUMBER: 314.118, SYNTHES LOT NUMBER: 7736365 , SUPPLIER LOT NUMBER: N/A , RELEASE TO WAREHOUSE DATE: 14-JUL-2014 , EXPIRATION DATE: N/A , MANUFACTURED BY (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: IT WAS REPORTED THAT THE STARDRIVE SCREWDRIVER T25 (314.118) BROKE WHILE ATTEMPTING TO REMOVE COLD WELDED SCREWS FROM A LISS PLATE DURING A REVISION PROCEDURE. THE STARDRIVE SCREWDRIVER T25 (314.118) IS NOTED IN FOUR SYSTEM TECHNIQUE GUIDES: 3.5MM AND 4.5MM CURVED LCP , 4.5MM VA-LCP CURVED CONDYLAR PLATE, LARGE FRAGMENT LCP INSTRUMENT AND IMPLANT SET AND LCP DYNAMICS HELICAL HIP SYSTEM . IN EACH SYSTEM THE DRIVER IS AVAILABLE FOR INSERTION AND REMOVAL OF SCREWS WITH T25 DRIVE RECESSES. THE RETURNED DEVICE WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DISTAL TIP WAS FOUND TO HAVE CHIPS OF MATERIAL MISSING FROM TWO OF THE LOBES. ADDITIONALLY IT WAS NOTED THAT THE TIP WAS TWISTED COUNTERCLOCKWISE IN A MANNER CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE DURING ATTEMPTED IMPLANT REMOVAL, AS DESCRIBED IN THE COMPLAINT DESCRIPTION. THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED DUE TO POST-MANUFACTURING DAMAGE. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE): TOP-LEVEL AND SHAFT . THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. NO DIMENSIONAL ANALYSIS IS POSSIBLE DUE TO POST-MANUFACTURING DAMAGE. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL AND HARDNESS REVIEWS, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿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.

    Additional Manufacturer Narrative · 1

    (B)(6). PATIENT¿S WEIGHT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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.

    Description of Event or Problem · 1

    FURTHER IT WAS CLARIFIED THAT THE PATIENT HAD A FRACTURE WHICH WAS SLIGHTLY DISTAL TO THE SYNTHES LISS FEMUR PLATE AND THE PLAN WAS TO REVISE THE PATIENT TO ANOTHER ZIMMER PLATE. HENCE THE REVISION SURGERY WAS CONDUCTED. HE ALSO SAID THAT ALL PARTS THAT WERE IMPLANTED EARLIER WERE INTACT WHEN THE SURGERY BEGAN AND THE SCREWS THAT WERE COLD WELDED WERE THE ONLY ONES THAT BROKE / GOT DAMAGED TO REMOVE THEM DURING THE SURGERY. THIS REPORT ADDRESSES INTRAOPERATIVE ISSUE OF THREE (3) BROKEN SCREWDRIVERS AND THREE COLD WELDED / CROSS THREADED SCREWS THAT WERE STUCK TO THE PLATE. THE POSTOPERATIVE REVISION DUE TO PATIENT¿S FRACTURE WHICH WAS SLIGHTLY DISTAL TO THE SYNTHES LISS FEMUR PLATE HAS BEEN CAPTURED UNDER LINKED (B)(4). CONCOMITANT DEVICES REPORTED: SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 10), LISS PLATE (PART # 422.348, LOT # 2142869, QUANTITY # 1). THIS IS REPORT 1 OF 6 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY ON (B)(6) 2017, TO REMOVE A SYNTHES TITANIUM DISTAL FEMUR LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE AND THIRTEEN (13) SCREWS, THREE (3) SYNTHES SCREWDRIVERS BROKE WHEN THE SURGEON ATTEMPTED TO REMOVE THREE (3) COLD WELDED / CROSS THREADED SCREWS FROM THE PLATE. 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 INTRAOPERATIVE ISSUE OF THREE (3) BROKEN SCREWDRIVERS. THE INTRAOPERATIVE ISSUE OF COLD WELDED / CROSS THREADED SCREWS THAT WERE STUCK TO THE PLATE HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 13), LISS PLATE (PART # 422.348, LOT # 2142869, QUANTITY # 1). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T25. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896689 STARDRIVE SCREWDRIVER T25 SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7736365 10886982188557

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR