BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 8037280 · Received November 5, 2018

    Report

    Report Number
    2939274-2018-54764
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Report Date
    September 14, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART: 319.006; SYNTHES LOT: 7971080; SUPPLIER LOT: NA; RELEASE TO WAREHOUSE DATE: APRIL 08, 2015; MANUFACTURED BY SYNTHES (B)(4). NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. 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. INVESTIGATION FLOW: BROKEN: DEVICE CONDITION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY OBSERVED BROKEN NEEDLE ON THE RETURNED DEPTH GAUGE AND A MISSING BALL BEARING ON THE SLIDER BODY. THE NEEDLE OF THE DEPTH GAUGE IS BROKEN OFF RIGHT AT THE SLIDER BODY. THE BALL BEARING IS MISSING AND WAS NOT RETURNED, THE HOLE ON THE SLIDE BODY IS DEFORMED. ALL REMAINING COMPONENTS OF THE DEPTH GAUGE SHOWED MINIMAL SIGNS OF WEAR. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION. THE DEVICE CONDITION AGREE WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT WAS CONFIRMED. THE CAUSE FOR THIS COMPLAINT CONDITION CANNOT BE DEFINITELY DETERMINED TO BE USE ERROR, MISUSE/ABUSE, NON-COMPLIANCE, OR POSTOPERATIVE TRAUMA. DIMENSIONAL ANALYSIS AND DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWINGS FOR THE RETURNED DEVICE (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE) WERE REVIEWED, AND NO DESIGN ISSUES WERE NOTED. FINAL ASSEMBLY NEEDLE DIMENSIONAL INSPECTION: NEEDLE SHAFT SPECIFICATION: Ø 1.25 +0/- 0.05 MM ; NEEDLE MEASURED DIMENSIONS: SHAFT Ø: 1.25 MM; CONFORMING . DIMENSIONAL INSPECTION OF THE BALL BEARING AND SLIDER BODY HOLE CANNOT BE PERFORMED DUE TO THE DAMAGE TO THE SLIDER BODY AND THE MISSING BALL BEARING. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT ANY UNINTENDED EXCESSIVE FORCES SUCH AS DEVICE BEING DROPPED DURING USAGE/HANDLING COULD HAVE CONTRIBUTED TO COMPLAINT CONDITION. THE MATERIAL USED DURING PRODUCTION WAS REVIEWED, AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO RELEVANT NON-CONFORMANCE NOTED. CONCLUSION: THE OVERALL COMPLAINT CONDITION WAS CONFIRMED; HOWEVER, NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING THIS INVESTIGATION. 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 DURING A ROUTINE INSPECTION ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE BALL BEARING WAS MISSING FROM THE SLIDER BODY OF THE DEPTH GAUGE. THERE WAS NO PATIENT/PROCEDURE 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
    877281 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7971080 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1