BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    MDR report key: 9886250 · Received March 26, 2020

    Report

    Report Number
    2939274-2020-01551
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Report Date
    February 28, 2020
    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
    WI, 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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: PART NUMBER: 03.614.017, LOT NUMBER: T130088, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: 30-NOV-2015. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE HOLDING SLEEVE (P/N 03.614.017, LOT # T130088) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE THREADS OF THE DEVICE SHOWED NO SIGNS OF STRIPPING OR DAMAGE. THEREFORE, THE COMPLAINT IS NOT CONFIRMED. FUNCTIONAL TEST: A FUNCTIONAL TEST COULD NOT BE PERFORMED SINCE THE HOLDING SLEEVE WAS RETURNED BY ITSELF. ALSO, THERE WERE NO VISUAL DEFECTS FOUND. THE COMPLAINT WAS NOT ABLE TO BE REPLICATED, THEREFORE, THE COMPLAINT IS NOT CONFIRMED. DEVICE FAILURE/ DEFECT IDENTIFIED? NO. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE THE OUTER THREADED DIAMETER OF THE SHAFT WAS MEASURED TO BE WITHIN SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. SPRING LOADED THREADED DRIVER SLEEVE. INNER SLEEVE THREADED DRIVER SLEEVE. COMPLAINT CONFIRMED? NO. CONCLUSION: THE COMPLAINT CONDITION IS NOT CONFIRMED AS HOLDING SLEEVE (P/N 03.614.017, LOT # T130088) SHOWED NO SIGNS OF STRIPPED/ DAMAGED THREADS WHICH COULD HAVE RESULTED IN NON-INTERACTION WITH THE SCREW. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCRUB TECHNICIAN DISCOVERED THAT NEITHER OF THE TWO (2) SYNAPSE HOLDING SLEEVES IN THE SET WERE PROBABLY THREADING INTO THE HEAD OF THE SCREW. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE PLOYAXIAL SCREWS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349594 THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.614.017 T130088 10705034714882

    Patients

    Seq Age Sex Outcome Treatment
    1 THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS.| UNK - SCREWS: TRAUMA.