BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 7763083 · Received August 8, 2018

    Report

    Report Number
    2939274-2018-53242
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Report Date
    June 12, 2018
    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

    NO PATIENT INVOLVEMENT REPORTED. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 319.006, LOT# 7910790. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: FEB 05, 2015. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. THE DEPTH GAUGE WAS INSPECTED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE NEEDLE OF THE DEPTH GAUGE WAS BROKEN OFF AND THE NEEDLE WAS NOT RETURNED. THE COMPLAINT CONDITION WAS VISUALLY CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. NO NEW MALFUNCTIONS HAVE BEEN IDENTIFIED. THE DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED AS THE RELEVANT COMPONENT (NEEDLE) WAS NOT RETURNED. RELEVANT DRAWINGS WERE REVIEWED. NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION. DURING THE CQ INVESTIGATION, THE MATERIAL REVIEW WAS PERFORMED, AND THE MATERIAL WAS DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE. THE COMPLAINT CONDITION IS CONFIRMED AS THE DEPTH GAUGE (PART: 319.006) WAS RECEIVED BROKEN. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES (SUCH AS BEING DROPPED, STRUCK OFF-AXIS OR DAMAGED DURING USAGE OR HANDLING OR STERILE PROCESSING). BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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, THREE (3) DEPTH GAUGES AND ONE (1) DYNAMIC HIP SYSTEM (DHS) COUPLING SCREW WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT (SPD). THE METAL PART OF THE DEPTH GAUGES WERE BROKEN BY THE WIRE PORTION. THE COUPLING SCREW BROKE AT THE THREADS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603249 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7910790 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1