BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMPF TABLE TOP RAIL SECTION CLAMP (US)

    MDR report key: 6637284 · Received June 13, 2017

    Report

    Report Number
    1221538-2017-00001
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    May 10, 2017
    Report Date
    May 17, 2017
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEN MEDICAL HAS RECEIVED THE CLAMPS, FROM THE USER FACILITY, FOR INVESTIGATION. THE PARTS HAVE BEEN NOT BEEN EVALUATED AT THE TIME OF THIS REPORT. TESTING WAS PERFORMED WITH A CLAMP, FROM INVENTORY, WHERE THE WHITE LOCK RELEASE TABS ON BOTH CLAMPS WERE BROKEN OFF, IT WAS FOUND TO SUPPORT THE SPECIFIED WEIGHT LIMIT. THE WHITE LOCK RELEASE TAB SERVES ONLY AS A HAND HOLD TO RELEASE THE CLAMP AND HAVE NO SUPPORT FUNCTION. ADDITIONAL TESTING AND ANALYSIS OF THE RETURNED CLAMPS IS ONGOING AND A FOLLOW-UP REPORT WILL BE SENT FOLLOWING THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION REVEALED THAT WHEN THE TRUMPF TABLE TOP RAIL SECTION CLAMP (F-T3RAILSC) IS USED TO SUPPORT THE TRUMPF TABLE TOP LEG SUPPORT, THE WEIGHT OF THE LEG MAY EXCEED THE CAPACITY OF THE TRUMPF TABLE TOP RAIL SECTION CLAMPS RESULTING IN A LOSS OF STRUCTURAL INTEGRITY. AS AN INDIVIDUAL COMPONENT, THE TRUMPF TABLE TOP RAIL SECTION CLAMP WAS NOT DESIGNED TO BE USED AS A TRUMPF TABLE TOP LEG SUPPORT CLAMP AND IS LABELED ¿FOR USE WITH ARMBOARDS ONLY¿ UPON FURTHER REVIEW OF THE LABELING, THE INSTRUCTION FOR USE (IFU) D-720595, REV A3, PAGE 6 INCORRECTLY IDENTIFIES THAT THE TRUMPF TABLE TOP RAIL SECTION CLAMP CAN BE USED TO SUPPORT A TRUMPF TABLE TOP LEG SUPPORT ASSEMBLY. THE FOLLOWING STEPS ARE BEING TAKEN FOR THIS FIELD CORRECTION. CUSTOMER NOTIFICATION WILL BE SENT TO CONSIGNEES INFORMING THEM OF THE POTENTIAL HAZARD AND REQUESTING THEY TAKE THE UNITS OUT OF SERVICE. THE CONSIGNEES WILL BE SHIPPED THE CORRECT LEG CLAMP FOR THE TRUMPF TABLE TOP SYSTEM AND REVISED INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    ALLEN MEDICAL RECEIVED A REPORT STATING, DURING A SPINAL SURGERY THE CLAMPS OF THE LEG SUPPORT UNEXPECTEDLY RELEASED CAUSING THE PATIENTS LEGS TO FALL. THE PATIENT WAS POSITIONED ON THEIR ABDOMEN WITH THEIR LEGS SUPPORTED AT APPROXIMATELY 45-DEGREE ANGLE ON THE LEG SUPPORT. THERE WAS NO PATIENT INJURY CAUSED BY THE EVENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. UPON INSPECTION OF THE FOOT SUPPORT AND CLAMPS, THE USER FACILITY NOTED THE WHITE LOCK RELEASE TABS ON BOTH CLAMPS WERE BROKEN OFF. THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS (B)(4).

    Description of Event or Problem · 1

    ALLEN MEDICAL RECEIVED A REPORT STATING, DURING A SPINAL SURGERY THE CLAMPS OF THE LEG SUPPORT UNEXPECTEDLY RELEASED CAUSING THE PATIENTS LEGS TO FALL. THE PATIENT WAS POSITIONED ON THEIR ABDOMEN WITH THEIR LEGS SUPPORTED AT APPROXIMATELY 45-DEGREE ANGLE ON THE LEG SUPPORT. THERE WAS NO PATIENT INJURY CAUSED BY THE EVENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. UPON INSPECTION OF THE FOOT SUPPORT AND CLAMPS, THE USER FACILITY NOTED THE WHITE LOCK RELEASE TABS ON BOTH CLAMPS WERE BROKEN OFF. THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418066 TRUMPF TABLE TOP RAIL SECTION CLAMP (US) RAIL CLAMP FWZ ALLEN MEDICAL SYSTEMS, INC. F-T3RAILSC-A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other