BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16MM CANN PERCUTANEOUS HOLLOW DRILL BIT

    MDR report key: 8573681 · Received May 2, 2019

    Report

    Report Number
    2939274-2019-57772
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 4, 2019
    Report Date
    April 4, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982070531
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. COMPONENT PART 03.037.004, LOT 160236-201 WAS RECEIVED. PART 03.037.004, LOT 160236-201: MANUFACTURING SITE: SELZACH. SUPPLIER: LEITNER AG. RELEASE TO WAREHOUSE DATE: AUGUST 29, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION IDENTIFIED THAT THE NITINOL SPRING COMPONENT ON THE CENTERING ATTACHMENT SUB-ASSEMBLY IS MISSING. THE WELD THAT SECURED THE SPRING TO THE BODY HAS FAILED. THE RELEVANT DRAWINGS WERE REVIEWED. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. A RELEVANT DIMENSIONAL INSPECTION IS NOT POSSIBLE FOR THE CONDITIONS OF A FAILED WELD AND MISSING SPRING. A DEFINITIVE ROOT CAUSE FOR THE MISSING SPRING COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS SYNTHES SALES CONSULTANT. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PIN FROM THE CENTERING SLEEVE WAS BROKEN ON THE HOLLOW REAMER LONG CANNULATED WHEN THE SET WAS OPENED TO BE USED FOR SURGERY ON (B)(6) 2019. THE INSTRUMENT WAS UNUSABLE, AN ALTERNATIVE INSTRUMENT WAS USED WHICH WAS APPROPRIATE FOR THE SURGERY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 16MM CAN PERCUTANEOUS HOLLOW DRILL BIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366809 16MM CANN PERCUTANEOUS HOLLOW DRILL BIT MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.104 10886982070531

    Patients

    Seq Age Sex Outcome Treatment
    1