BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 12561070 · Received October 1, 2021

    Report

    Report Number
    2939274-2021-05862
    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
    10886982069351
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE RADIOLUCENT INSERTION HANDLE FRN (P/N: 03.010.523, LOT # 8953342) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE RECEIVED DEVICE SHOWED THE THREADED DISTAL TIP BROKEN AND THE BROKEN TIP OF THE DRIVING CAP WAS STUCK IN THE MATING DEVICE INSERTION HANDLE (PI-16324046622358849). THE DEVICE HAD SURFACE SCRATCHES ALONG THE SHAFT BUT HAS NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. DIMENSIONAL INSPECTION: MEASURED DIMENSIONS: GROOVE = CONFORMING. SHAFT= CONFORMING. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE DRIVING CAP/THREADED (PART # 03.010.523, LOT # 8953342). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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: 03.010.523, LOT: 8953342, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 29.JULY 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, 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, (1) RADIOLUCENT STANDARD INSERTION HANDLE, (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM CORTEX SCREWS, AND (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 (1) DRIVING CAP/THREADED. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458496 DRIVING CAP/THREADED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 8953342 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| RADIOLUCENT INSRT H&LE FOR EXPERT NL/100| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| RADIOLUCENT INSRT H&LE FOR EXPERT NL/100