BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.0MM STERNAL CABLE-LONG

    MDR report key: 1820705 · Received August 27, 2010

    Report

    Report Number
    1719045-2010-00225
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    June 28, 2010
    Report Date
    August 13, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    PMA / PMN Number
    K031508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE LOTS FOR THIS COMPLAINT: 6249001, 6034242, 6031078. EXPIRATION DATES: 6249001: 09/28/2018, 6034242: 10/02/2017, 6031078: 10/25/2017. MANUFACTURING DATES FOR THE POSSIBLE LOTS ARE: 6249001: OCTOBER 2009, 6034242: DECEMBER 2008, 6031078: NOVEMBER 2008. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. DEVICE HISTORY RECORD REVIEWS HAVE BEEN REQUESTED FOR ALL POSSIBLE LOTS.

    Description of Event or Problem · 1

    DURING A PROCEDURE, SURGEON PLACED SIX CABLES, 1.0 MM STERNAL CABLE, IN A SINGLE LOOP. IN 5 OF THE SIX CABLES, THE SURGEON STRUGGLED CUTTING THE CABLES WITH THE TENSIONER / CRIMPER / CUTTER. SURGEON DID HAVE TO CUT SOME OF THE STRANDS OF CABLE BY HAND. THE FIXATION WAS SOLID AND THE CRIMPING APPEARED TO BE OK. ONE DAY LATER, PT INFORMED SURGEON THAT WHEN TURNING IN BED, A CRACK WAS HEARD AND UPON EXAMINATION, 5 OF THE SIX CABLES HAVE COME LOOSE. THE HARDWARE WAS REMOVED. THIS IS FOUR OF SEVEN REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.0MM STERNAL CABLE-LONG STERNAL CABLES JDQ SYNTHES MONUMENT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention TENSIONER/CRIMPER/CUTTER