BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM VA LCK SCREW SLF-TAP

    MDR report key: 14085689 · Received April 12, 2022

    Report

    Report Number
    2939274-2022-01260
    Event Type
    Injury
    Date Received
    April 12, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    07611819435421
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT HAD A DISPLACED COMMINUTED ACUTE OLECRANON FRACTURE RIGHT ELBOW WHICH WAS FIXED WITH A SYNTHES OLECRANON LOCKING PLATE, 5 SCREWS IN THE SHAFT WITH BICORTICAL FIXATION, AND 4 LOCKING UNICORTAL SCREWS IN THE PROXIMAL SEGMENT. ON OR ABOUT DECEMBER 2016, SYNTHES ANNOUNCED A RECALL OF THE SYSTEM DUE TO THE DISCOVERY THAT THE SYSTEM WAS DEFECTIVE AND COULD CAUSE THE RADIAL STEM TO LOOSEN POST-OPERATIVELY AT THE STEM BONE INTERFACE. ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION DUE TO PAIN, RIGHT ELBOW RETAINED HARDWARE, OSTEOLYSIS SECONDARY TO LOOSE IMPLANT - RADIAL HEAD, AND FAILED RADIAL HEAD ARTHROPLASTY. OPERATIVE FINDINGS DISCOVERED HYPERTHROPY AND SYNOVITIS, CHONDROMALACIS OF CAPITELLUM GRADE II, GRADE II WITH PERIPHERAL SPUR. THE OLECRANON FRACTURE HEALED WITHOUT ANY LOOSENING OR EVIDENCE OF ANY OSTEOLYSIS AROUND OLECRANON PLATE AND SCREWS. THIS IS REPORT 8 OF 12 FOR (B)(4).

    Description of Event or Problem · 0

    UPDATE: ON (B)(6), 2015 PATIENT HAD A DISPLACED COMMINUTED ACUTE OLECRANON FRACTURE RIGHT ELBOW AND NECK FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278589 2.7MM VA LCK SCREW SLF-TAP SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 07611819435421

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention 2.7/3.5 VA-LCP OLECRANON PL 2H/RT/90| 2.7MM VA LCK SCREW SLF-TAP| 2.7MM VA LCK SCREW SLF-TAP| 2.7MM VA LCK SCREW SLF-TAP| 2.7MM VA LCK SCREW SLF-TAP| 2.7MM VA LCK SCREW SLF-TAP| 2.7MM VA LCK SCREW SLF-TAP| 22 COCR RADIAL HEAD STD HEIGHT/12.5-SILE| 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE| UNK - SCREWS: 3.5 MM CORTEX| UNK - SCREWS: 3.5 MM CORTEX| UNK - SCREWS: 3.5 MM CORTEX