BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 9967418 · Received April 16, 2020

    Report

    Report Number
    2939274-2020-01862
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Report Date
    March 23, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982196255
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER: 357.402. SYNTHES LOT NUMBER: 5760030. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: APRIL 10, 2008. EXPIRATION DATE: N/A. MANUFACTURED BY SYNTHES BRANDYWINE. NO 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. THE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS (P/N: 357.402, LOT NUMBER: 5760030) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, THE BALL AND COMPRESSION SPRING COMPONENTS ARE MISSING. THE SHAFT IS ALSO BENT IN THE MIDDLE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: DRAWING. SPECIFIED DIMENSIONS: SHAFT DIAMETER = 2.5 +0/-0.1MM. MEASURED DIMENSIONS: SHAFT DIAMETER = 2.45MM, CONFORMING. DEVICE USED - CALIPER CA802. DIMENSIONAL ANALYSIS ON THE HOLE FOR THE MISSING BALL AND COMPRESSION SPRING COMPONENTS COULD NOT BE PERFORMED DUE TO DEFORMATION FROM THE STAKING PROCESS THAT HAPPENS DURING FINAL ASSEMBLY. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. CURRENT AND MANUFACTURED WERE ALSO REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS (P/N: 357.402, LOT NUMBER: 5760030) AS THE BALL AND COMPRESSION SPRING COMPONENTS ARE MISSING AND THE SHAFT IS BENT IN THE MIDDLE. 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. 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 ON AN UNKNOWN DATE, A LOCKING BOLT MEASURING DEVICE WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431539 LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 357.402 5760030 10886982196255

    Patients

    Seq Age Sex Outcome Treatment
    1