BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEXAGONAL SCREWDRIVER LONG

    MDR report key: 10422290 · Received August 18, 2020

    Report

    Report Number
    2939274-2020-03613
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Report Date
    August 5, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188724
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS CONDUCTED: INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE LARGE HEXAGONAL SCREWDRIVER LONG (P/N: 314.26, LOT NUMBER: 4962854) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE HANDLE HAD A LARGE PIECE BROKEN OFF. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE HANDLE HAS A LARGE PIECE BROKEN OFF. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 NUMBER: 314.260. SYNTHES LOT # 4962854. SUPPLIER LOT # NA. RELEASE TO WAREHOUSE DATE: MAR 10, 2005. MANUFACTURED BY SYNTHES (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW. 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 (B)(6) 2020, THE STERILE PROCESSING DEPARTMENT (SPD) REPORTED THAT THE TWO (92) LARGE HEXAGONAL SCREWDRIVERS WERE FOUND TO HAVE DAMAGED HANDLES. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) LARGE HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884512 LARGE HEXAGONAL SCREWDRIVER LONG SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.26 4962854 10886982188724

    Patients

    Seq Age Sex Outcome Treatment
    1