BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 5443724 · Received February 18, 2016

    Report

    Report Number
    1719045-2016-10139
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Report Date
    January 26, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS REPORTED; IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). PART 391.201, LOT P318228: EARLIEST RELEASE TO WAREHOUSE DATE: APRIL 13, 2007, (NOTE: 20 DEVICES RELEASED APRIL 13, 2007, 15 DEVICES RELEASED APRIL 16, 2007, 10 DEVICES RELEASED MAY 2, 2007, AND 8 DEVICES RELEASED JUNE 13, 2007). MANUFACTURING SITE IS (B)(4) AND SUPPLIED BY (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    MANUFACTURING INVESTIGATION EVALUATION: ONE CABLE TENSIONER WAS RECEIVED AND FOUND TO PASS FUNCTIONAL INSPECTION WITH VERIFIED MEASUREMENTS OF 38.2, 36.2, & 37.2 KG. THE DEVICE PASSED INSPECTION WITH NO VISUAL BLOCKAGE FOUND. DESTRUCTIVE TESTING WAS COMPLETED ON (B)(4) 2016, WHICH DID NOT IDENTIFY ANY FAILURE MODE(S). THE DEVICE FUNCTIONED AS INTENDED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND FOUND THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED AND/OR CONFIRMED. DEVICE 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CABLE TENSIONER IS JAMMED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CLARIFICATION: NO REPORTED PATIENT OR PROCEDURAL INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102480 CABLE TENSIONER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P318228

    Patients

    Seq Age Sex Outcome Treatment
    1