BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP OLECRANON PL 8H/LT/169MM-STER

    MDR report key: 14602757 · Received June 6, 2022

    Report

    Report Number
    2939274-2022-02101
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    May 9, 2022
    Report Date
    June 6, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982029393
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. (B)(4). 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. H10 ADDITIONAL NARRATIVE: D2B ADDITIONAL DEVICE PRODUCT CODES: HWC. D4: LOT AND EXPIRATION DATE. H3, H4, H6: PART # 02.107.308S, SYNTHES LOT # 6960619, SUPPLIER LOT # N/A, RELEASE TO WAREHOUSE DATE: 15 JUN 2012, MANUFACTURED BY: ELMIRA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THERE WAS NO DAMAGE OR DEFECTS WITH THE VA-LCP OLECR PL 2.7/3.5 LE 8HO L169 SST (PRODUCT CODE: 02.107.308S LOT NUMBER: 6960619). A DIMENSIONAL INSPECTION WAS PERFORMED FOR THE VA-LCP OLECR PL 2.7/3.5 LE 8HO L169 SST (PRODUCT CODE: 02.107.308S LOT NUMBER: 6960619) AND MET SPECIFICATIONS. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE VA-LCP OLECR PL 2.7/3.5 LE 8HO L169 SST (PRODUCT CODE: 02.107.308S LOT NUMBER: 6960619) WAS FOUND TO HAVE NO DAMAGE OR DEFECTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT 2.7MM VA LOCKING SCREWS OF VARIOUS LENGTHS BROKE DURING REMOVAL. THERE IS REPORTED SURGICAL DELAY OF 30 MINUTES. THIS COMPLAINT INVOLVES ONE (1) DEVICE VA-LCP OLECR PL 2.7/3.5 LE 8HO L169 SST. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 0

    THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154352 2.7MM/3.5MM VA-LCP OLECRANON PL 8H/LT/169MM-STER PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.107.308S 6960619 10886982029393

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention UNK - SCREWS: 2.7 MM SELF-TAPPING| UNK - SCREWS: 2.7 MM SELF-TAPPING| UNK - SCREWS: 2.7 MM SELF-TAPPING| UNK - SCREWS: 2.7 MM SELF-TAPPING| UNK - SCREWS: 2.7 MM VA LOCKING| UNK - SCREWS: 2.7 MM VA LOCKING| UNK - SCREWS: 2.7 MM VA LOCKING| UNK - SCREWS: 2.7 MM VA LOCKING| UNK - SCREWS: 2.7 MM VA LOCKING| UNK - SCREWS: 2.7 MM VA LOCKING