BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 5150827 · Received October 14, 2015

    Report

    Report Number
    1719045-2015-10673
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    October 1, 2015
    Report Date
    October 2, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURING INVESTIGATION EVALUATION: THIS DEVICE IS NOT ABLE TO FUNCTION AS DESIGNED DUE TO THE NOSE PIECE BEING OFF THE INSTRUMENT. THE NOSE PIECE IS ESSENTIAL FOR BEING TIGHTLY ATTACHED TO THE INSTRUMENT IN ORDER FOR THE JAWS TO BE ABLE TO OPEN AND RELEASE THE CABLE. THE RETURNED DEVICE FAILED VISUAL INSPECTION UPON INITIAL INSPECTION. THIS DEVICE IS NOT ABLE TO FUNCTION AS DESIGNED DUE TO THE NOSE PIECE BEING OFF THE INSTRUMENT. SINCE THE NOSE PIECE IS NOT ATTACHED, THIS WILL NOT ALLOW THE JAWS TO RELEASE THE CABLE. THIS DEVICE LOT WAS MANUFACTURED IN 2001. PIONEER SURGICAL HAS UPDATED THE DESIGN OF THIS INSTRUMENT (IN 2005) REQUIRING THAT THE NOSE PIECE BE EPOXIED IN PLACE DURING THE MANUFACTURING PROCESS. THUSLY, HELPING TO PREVENT IT FROM LOOSENING. THE MANUFACTURING OF THIS DEVICE WAS SUPERSEDED BY SYNTHES PART NUMBER 391.201. THE MANUFACTURING PROCESS FOR THIS DEVICE INCORPORATES A LASER WELD TO AFFIX THE NOSE PIECE. THE ROOT CAUSE OF THIS ISSUE IS THAT THE NOSE TIP UNSCREWED FROM THE TENSIONER. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORD REVIEW FOR PART 391.201, LOT P507071: RELEASE TO WAREHOUSE DATE: 03 OCTOBER 2001. SUPPLIER - (B)(4). 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. 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 WHILE USING THE CABLE TENSIONER DURING A PERI PROSTHETIC DISTAL FEMUR PROCEDURE ON (B)(6) 2015, THE CABLE/WIRE WOULD NOT RELEASE. THE TENSIONER NEEDED TO BE BROKEN DOWN AND THE CABLE CUT IN ORDER TO REMOVE THE DEVICE. A BACK-UP WAS AVAILABLE FOR USE. A FIVE (5) MINUTE SURGICAL DELAY WAS NOTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678021 CABLE TENSIONER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P507071

    Patients

    Seq Age Sex Outcome Treatment
    1