BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINDLE FOR EVOLUTION

    MDR report key: 10741177 · Received October 27, 2020

    Report

    Report Number
    2939274-2020-04832
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Report Date
    September 29, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034732022
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPINDLE FOR EVOLUTION (PART #:03.825.002, LOT #: H143328) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE WELD CONNECTING THE KNOB WITH THE SPINDLE WAS BROKEN ALLOWING THE KNOB TO ROTATE AND DISASSEMBLE FROM THE SPINDLE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. THE COMPLAINT CONDITION IS CONFIRMED FOR THE SPINDLE FOR EVOLUTION (PART #: 03.825.002, LOT #: H143328). NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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 HISTORY LOT: PART #: 03.825.002, SYNTHES LOT #: H143328, SUPPLIER LOT #: H143328, RELEASE TO WAREHOUSE DATE: (B)(4) 2016, SUPPLIER: (B)(4). THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS MALDEN, MA SITE, IT WAS OBSERVED THAT A SPINDLE FOR EVOLUTION WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207292 SPINDLE FOR EVOLUTION ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.825.002 H143328 10705034732022

    Patients

    Seq Age Sex Outcome Treatment
    1