BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 8956052 · Received September 3, 2019

    Report

    Report Number
    2939274-2019-60268
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 5, 2019
    Report Date
    August 5, 2019
    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
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEPTH GAUGE FOR 2.0 MM AND 2.4 MM SCREWS (P/N 319.006, LOT 9853457) WAS RECEIVED WITH THE NEEDLE COMPONENT BROKEN FROM THE SLIDER. THE TRANSVERSE FRACTURE OF THE NEEDLE IS LOCATED AT THE INTERFACE BETWEEN THE NEEDLE AND SLIDER. THE DISTAL PORTION OF THE NEEDLE WAS OBSERVED TO BE BENT OFF-AXIS. NO OTHER ISSUES WERE IDENTIFIED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE COMPLAINT CONDITION IS CONFIRMED FOR THE DEPTH GAUGE FOR 2.0 MM AND 2.4 MM SCREWS (P/N 319.006, LOT 9853457) AS THE NEEDLE COMPONENT WAS BROKEN FROM THE SLIDER. THE TRANSVERSE FRACTURE OF THE NEEDLE IS LOCATED AT THE INTERFACE BETWEEN THE NEEDLE AND SLIDER. THE DISTAL PORTION OF THE NEEDLE WAS OBSERVED TO BE BENT OFF-AXIS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING DEVICE USE, LEADING TO BENDING AND BREAKAGE. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: PART # 319.006, SYNTHES LOT # 9853457, SUPPLIER LOT # NA, RELEASE TO WAREHOUSE DATE: 20 JUL 2015. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. MANUFACTURED BY SYNTHES (B)(4). 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) 2019, DURING AN OPEN REDUCTION AND INTERNAL FIXATION CLAVICLE THE DEPTH GAUGE WAS BROKEN. THERE WAS NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0 MM AND 2.4 MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748424 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.006 9853457 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1