BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 10466824 · Received August 28, 2020

    Report

    Report Number
    2939274-2020-03861
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Report Date
    July 17, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982189943
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. PART:319.006. SYNTHES LOT: 6935003. SUPPLIER LOT: N/A. RELEASE TO WAREHOUSE DATE: MAY 03, 2012. EXPIRATION DATE: N/A. MANUFACTURED BY SYNTHES (B)(4). NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS NOTICED THAT THE NEEDLE COMPONENT IS BENT TOWARDS THE DISTAL END AND THE PROTECTION SLEEVE COMPONENT IS MISSING. DIMENSIONAL INSPECTION: NEEDLE DIAMETER = CONFORMING DOCUMENT/SPECIFICATION REVIEW: CURRENT) AND MANUFACTURED REVISIONS NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS AS THE DEVICE WAS BENT TOWARDS THE DISTAL END AND IS MISSING THE PROTECTION SLEEVE. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 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 DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WAS OBSERVED TO HAVE A MISSING PIECE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR A DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930702 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.006 6935003 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1