BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM COVERED BALE LOCK KNEE JOINT

    MDR report key: 173328 · Received June 19, 1998

    Report

    Report Number
    MW4002271
    Event Type
    Malfunction
    Date Received
    June 19, 1998
    Date of Event
    May 1, 1998
    Report Date
    June 1, 1998
    Manufacturer
    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
    Product Code
    ISW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROBLEM: A NUMBER OF REPORTS OF KNEE JOINT LOCK DISENGAGEMENT HAVE BEEN REC'D INVOLVING KNEE-ANKLE-FOOT ORTHOSES. ACTION: STAFF RESPONSIBLE FOR PRESCRIBING, SUPPLYING, FITTING AND MAINTAINING ORTHOTIC DEVICES SHOULD ENSURE THAT: THE OTTO BOCK BALE LOCK KNEE JOINT IS USED IN ACCORDANCE WITH THE MFR'S RECOMMENDATIONS. THE BALE LOCK ARMS ARE NOT RIGIDLY JOINED TOGETHER. A FLEXIBLE LINK SHOULD BE USED WHEN JOINING THE ARMS. USERS ARE MADE AWARE OF THE NEED TO MANUALLY ENGAGE THE LOCK WHEN REQUIRED. BACKGROUND: THE MED DEVICES AGENCY HAS REC'D REPORTS OF THE COLLAPSE OF KNEE-ANKLE-FOOT ORTHOSES INCORPORATING OTTO BOCK BALE LOCK KNEE JOINTS. IN EACH CASE, THE COLLAPSE HAS BEEN ATTRIBUTED TO ONE OF THE PAIR OF JOINTS BEING UNLOCKED AT THE TIME OF FAILURE. THE INCIDENT INVESTIGATION AND EXAMINATION OF THE ORTHOSES IDENTIFIED VARIOUS DESIGN, MFG AND USER PRACTICES WHICH MAY HAVE CONTRIBUTED TO THE FAILURES. THE CO HAS ISSUED THE ATTACHED ORTHOTIC BULLETIN TO ADVISE CUSTOMERS OF THE INTENDED PURPOSE OF THE KNEE JOINTS AND HOW THEY SHOULD BE USED. OTTO BOCK BALE LOCK KNEE JOINTS ARE INTENDED BY THE MFR TO BE MANUALLY OPERATED. THE LOCKS DO NOT HAVE A SEMI-AUTOMATIC FUNCTION AND THE BALE ARM SPRINGS ARE NOT INTENDED TO ENGAGE THE LOCK. OTTO BOCK UK LTD IS CURRENTLY ADDRESSING THE ISSUE OF PROVIDING INSTRUCTIONS FOR USE WITH NEW KNEE JOINTS. SIMILAR INFO WILL BE INCLUDED IN TRAINING COURSES AND SALES SUPPORT SEMINARS. THIS JOINT IS NOT INTENDED TO BE USED AS A SEMI-AUTOMATIC KNEE LOCK. FOR SAFETY PURPOSES, THE PT SHOULD ALWAYS MANUALLY ENSURE THAT THE BALE ARMS ARE LOCKED WHEN THE ORTHOSIS IS IN EXTENSION. THE BALE ARMS ON THESE KNEE JOINTS SHOULD NEVER BE PERMANENTLY FIXED TOGETHER, IE WELDED OR BRAZED, AS THIS COULD RESULT IN BOTH LOCKS NOT CORRECTLY ENGAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM COVERED BALE LOCK KNEE JOINT SYSTEM COVERED BALE LOCK KNEE JOINT ISW OTTO BOCK ORTHOPEDIC INDUSTRY, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO