BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACTION BOOT SUBASSEMBLY

    MDR report key: 3057470 · Received October 27, 2005

    Report

    Report Number
    1221538-2006-00002
    Event Type
    Malfunction
    Date Received
    October 27, 2005
    Date of Event
    August 24, 2005
    Report Date
    September 21, 2005
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    HST
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUB ASSEMBLY MANUFACTURED BY ALLEN MEDICAL SYSTEM IS A PLASTIC BOOT ASSEMBLY WITH VELCRO STRAPS USED TO STABILIZE THE PT'S FOOT DURING A PROCEDURE. THE BOOT IS INTENDED TO BE USED WITH AN OVERALL HIP TRACTION SYSTEM. ALLEN MEDICAL SYSTEMS MANUFACTURES THE BOOT ASSEMBLY ONLY. EVAL SUMMARY: EXAMINATION OF THE BOOT ASSEMBLY SHOWED THAT THE LOCKING KNOB OF THE BOOT CLAMP COULD NOT BE PROPERLY INSTALLED IN THE CENTER OF THE RECEIVING RAIL SECTION OF THE CUSTOMER'S LEG TRACTION DEVICE DUE TO AN INTERFERENCE WITH A METAL TAB ON THE TRACTION DEVICE. THE TAB IS IN THE CENTER OF THE RAIL THEREFORE THE USER ATTACHED THE BOOT CLAMP ASSEMBLY OFF CENTER. REVIEW OF THE DEVICE HISTORY RECORDS AND EXAMINATION OF THE DEVICE IN QUESTION SHOWED THAT ALL OF THE ALLEN MEDICAL SYSTEMS' BOOT ASSEMBLY COMPONENTS WERE WITHIN SPECIFICATIONS AND THE DEVICE PASSES THE FINAL DEVICE ACCEPTANCE TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S REP THAT DURING A PROCEDURE THE INDIVIDUAL WITNESSED THE DOCTOR LEAN AGAINST THE BOOT ASSEMBLY CAUSING IT TO DETACH FROM THE MOUNT CLAMP AND RESULTING IN THE BOOT AND THE PT'S LEG FALLING TOWARD THE FLOOR. A PT SUPPORT FIXTURE HAD BEEN PLACED NEXT TO THE SURGICAL TABLE AND HELPED PREVENT THE LEG FROM FALLING ALL THE WAY DOWN. ALTHOUGH THE INCIDENT OCCURRED DURING THE PROCEDURE THE BOOT ASSEMBLY WAS REATTACHED AND THE DOCTOR WAS ABLE TO COMPLETE THE PROCEDURE WITH NO ADVERSE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACTION BOOT SUBASSEMBLY SURGICAL TABLE ACCESSORY HST ALLEN MEDICAL SYSTEMS F-TBMAQ-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention