BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUSRS

    MDR report key: 7642962 · Received June 27, 2018

    Report

    Report Number
    1119903-2018-00002
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Date of Event
    May 28, 2018
    Report Date
    May 29, 2018
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    ISD
    PMA / PMN Number
    K933611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO INJURY RELATED TO THE SHAFT ISSUE HAS BEEN REPORTED. DESPITE THE DEVICE MALFUNCTIONING, BASED ON THE DESIGN OF THE PRIMUS AND THE NATURE OF THE FRACTURE, EVIDENCE SHOWS THAT A PATIENT OR USER WILL BE AT MINIMAL RISK FOR INJURY. BTE PERFORMED AN ANALYSIS REVIEWING THE SHAFT FAILURE CONDITIONS. INSPECTION OF CROSS-SECTIONS OF THE LOAD CELL SHAFTS REVEALED THAT THE SHAFT WILL WITHSTAND THE RATED LOADS UNLESS A UNIQUE AND RARE SET OF MANUFACTURING CONDITIONS ARE ENCOUNTERED. THE POSSIBILITY OF THESE CONDITIONS OCCURRING ONLY EXISTS ON A SMALL SUBSET OF SHAFTS. THE PROBABILITY THAT A SHAFT WILL FRACTURE OR SEPARATE IS REMOTE. IT HAS BEEN DETERMINED THAT NO REMEDIAL ACTION IS NECESSARY. REF. H3: THE LOAD CELL SHAFT FROM THE REPORTER FACILITY'S DEVICE HAS BEEN EVALUATED BASED ON EVIDENCE PROVIDED BY THE USER. THERE WAS NO NEED TO INSPECT THE ENTIRE PRIMUS SYSTEM ON THE USER SITE. SHAFTS FROM INVENTORY AND SHAFTS FROM OTHER DISTRIBUTED SYSTEMS HAVE BEEN ALSO EVALUATED. SUSPECT SHAFTS UNDERWENT LOAD TESTING AT BTE, AND ALL PARTS PASSED THE TEST.

    Additional Manufacturer Narrative · 1

    BTE PERFORMED AN ANALYSIS REVIEWING THE SHAFT FAILURE CONDITIONS. INSPECTION OF CROSS-SECTIONS OF THE LOAD CELL SHAFTS UNCOVERED THAT THE SHAFT WILL NOT BE ABLE TO WITHSTAND THE RATED LOADS ONLY WHEN A UNIQUE AND RARE SET OF MANUFACTURING CONDITIONS ARE ENCOUNTERED. THE POSSIBILITY OF THESE CONDITIONS OCCURRING ONLY EXISTS ON A SMALL SUBSET OF SHAFTS. THE PROBABILITY THAT A SHAFT WILL FRACTURE OR SEPARATE IS REMOTE.

    Description of Event or Problem · 1

    PRIMUS LOAD CELL SHAFT FRACTURED AND SEPARATED WHILE PATIENT WAS EXERCISING ON THE PRIMUS. NO INJURY OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485023 PRIMUSRS PRIMUS ISD BTE TECHNOLOGIES, INC. PRIMUSRS

    Patients

    Seq Age Sex Outcome Treatment
    1