BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    MDR report key: 8817220 · Received July 23, 2019

    Report

    Report Number
    2939274-2019-59317
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    June 27, 2019
    Report Date
    June 27, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034714882
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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. THE HOLD-SL (P/N 03.614.017 LOT T142449) WAS RECEIVED AT CUSTOMER QUALITY, AND IT WAS OBSERVED THAT THE THREADS ON THE DISTAL END OF DEVICE WERE STRIPPED. THE COMPLAINT OF STRIPPED THREADS IS CONFIRMED. THE SUPERIOR SURFACE OF THE HOLDING SLEEVE SHOWS VISIBLE SIGNS OF WEAR CONSISTENT WITH NORMAL USE. FUNCTIONAL TEST CANNOT BE PERFORMED BECAUSE THE DEVICE WAS RECEIVED BY ITSELF. AN ACCURATE DIMENSIONAL INSPECTION OF THE STRIPPED TIP WAS NOT ABLE TO BE PERFORMED BECAUSE OF THE POST MANUFACTURING DEFORMATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. A REVIEW OF THE MANUFACTURING RECORD EVALUATIONS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A DEFINITIVE ASSIGNABLE ROOT CAUSE FOR THE POST MANUFACTURING DAMAGE 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 BECAUSE OF THIS EVALUATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT PART NUMBER: 03.614.017, LOT NUMBER: T142449, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: 20-SEP-2016. A REVIEW OF THE DEVICE HISTORY RECORDS 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 THE SURGEON HAD A DIFFICULT TIME LOADING THE SCREWS FROM THE SYNAPSE SYSTEM DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2019. IT WAS NOTED TWO (2) THREADED HOLDING SLEEVES APPEARED WORN AND MAY HAVE BEEN STRIPPED. THERE WAS NO SURGICAL DELAY OR PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613085 THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS MISC, ORTHO, SURGICAL, INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.614.017 10705034714882

    Patients

    Seq Age Sex Outcome Treatment
    1