BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT INSRT H&LE FOR EXPERT NL/100

    MDR report key: 12561072 · Received October 1, 2021

    Report

    Report Number
    2939274-2021-05860
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    January 1, 2021
    Report Date
    September 1, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982069047
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE INSERT-HANDLE RADIOLUC L100 (P/N: 03.010.486, LOT # 9200414) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THE BROKEN TIP OF THE MATING DRIVING CAP F/INSERTION HANDLE (P/N: 03.010.523, LOT # 8953342) WAS RETAINED IN THE THREADED PORTION OF THE INSERTION HANDLE. NO ISSUES WERE OBSERVED WITH THE DEVICE. NO, THE RECEIVED CONDITION OF THE DEVICE DID NOT AGREE WITH THE COMPLAINT DESCRIPTION AND WAS NOT CONFIRMED AS NO FRACTURES/BREAKS WERE OBSERVED ON THE RETURNED DEVICE. THE MATING DEVICE THE DRIVING CAP F/INSERTION HANDLE (P/N: 03.010.523, LOT # 8953342) WAS OBSERVED TO BE BROKEN AND WILL BE INVESTIGATED. CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED AS NO DAMAGE WERE OBSERVED ON THE INSERT-HANDLE RADIOLUC L100 (P/N: 03.010.486, LOT # 9200414). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE WERE IDENTIFIED. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.010.486. LOT: 9200414. MANUFACTURING SITE: HAGENDORF. SUPPLIER: N/A. RELEASE TO WAREHOUSE DATE: 20 JANUARY 2015. EXPIRATION DATE: N/A. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    UNKNOWN DATE IN 2021. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) RADIOLUCENT STANDARD INSERTION HANDLE, ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM CORTEX SCREWS, AND ONE (1) DRIVING CAP/THREADED WERE BROKEN DUE TO THE AMOUNT OF USE. NO WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS A PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSRT H&LE FOR EXPERT NL/100. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458498 RADIOLUCENT INSRT H&LE FOR EXPERT NL/100 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.486 9200414 10886982069047

    Patients

    Seq Age Sex Outcome Treatment
    1 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DRIVING CAP/THREADED| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DRIVING CAP/THREADED