BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 7113047 · Received December 13, 2017

    Report

    Report Number
    2939274-2017-50248
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 14, 2017
    Report Date
    November 14, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982198204
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. INITIAL REVIEW FOR UNKNOWN CONCOMITANT DEVICE (CABLE) IS AS FOLLOWS: THE CABLE WAS RECEIVED STUCK IN THE TENSIONER DUE TO THE JAMMED CONDITION AND FRAYING ON THE END DUE TO BEING CUT. UPON VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. 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.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 391.201, SYNTHES LOT NUMBER: P056867, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 02-DEC-2009, 29-DEC-2009, 21-JAN-2010, 11-FEB-2010, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS (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. A MANUFACTURING INVESTIGATION WAS PERFORMED. THE INSPECTION RESULTS OF THIS DEVICE ARE AS FOLLOWS: A CABLE IS STUCK IN THE TENSIONER. DESTRUCTIVE TESTING RESULTS ARE AS FOLLOWS: ONCE THE CABLE WAS REMOVED THE TENSIONER FUNCTIONED AS INTENDED. A DHR REVIEW HAS BEEN CONDUCTED AND CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. CORRECTED DATA: 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 A CABLE WAS JAMMED INSIDE THE CABLE TENSIONER. THIS OCCURRED DURING AN IN-SERVICE FOR SALES CONSULTANTS ON (B)(6) 2017. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT: (B)(4) QTY, UNKNOWN CABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893646 CABLE TENSIONER MISC ORTHO SURGICAL INSTRUMENT LXH WRIGHTS LANE : SYNTHES USA PRODUCTS LLC P056867 10886982198204

    Patients

    Seq Age Sex Outcome Treatment
    1