BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 4768821 · Received May 13, 2015

    Report

    Report Number
    2520274-2015-13821
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 22, 2015
    Report Date
    April 22, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING RELEASE DATE: MAY 21, 2012 SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW: LOT P112470 . PIONEER SURGICAL TECHNOLOGY MANUFACTURED THE CABLE TENSIONER (PART 391.201 / LOT P112470) ON SYNTHES PURCHASE ORDERS. THE SUPPLIER¿S CERTIFICATES OF COMPLIANCE (DATED APRIL 20, 2012 AND MAY 11, 2012), FOR TWO SEPARATE RECEIPTS OF THIS LOT, INDICATE THE PARTS WERE MANUFACTURED TO AND MET THE REQUIRED SPECIFICATIONS. THE FIRST RECEIPT OF THIS LOT WAS INSPECTED AND CONFORMED TO SYNTHES INCOMING FINAL INSPECTION SHEET. THE SECOND RECEIPT WAS INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET. NO NON-CONFORMANCE REPORTS WERE GENERATED FOR THIS LOT AND THE PARTS WERE RELEASED MAY 2, 2012 AND MAY 21, 2012. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: VISUAL INSPECTION FOUND THE DEVICE TO BE FREE FROM DAMAGE OR DEBRIS WHICH COULD NEGATIVELY AFFECT THE PERFORMANCE OF THE DEVICE. THE TENSIONER WAS INSTRUMENT MILKED AND TESTED THREE TIMES IN AN INLINE CONFIGURATION IN ACCORDANCE WITH THE WORK INSTRUCTION. ALL TEST RESULTS MEET SPECIFICATIONS. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THIS PRODUCT MET SPECIFICATION PRIOR TO SHIPPING. A MANUFACTURING ROOT CAUSE COULD NOT BE DETERMINED. UPON EVALUATION, THE DEVICE FUNCTIONED AS INTENDED. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: WE HAVE RECEIVED THIS CABLE TENSIONER FOR INVESTIGATION AND FORWARDED IT TO THE MANUFACTURING PLANT IN THE US; HERE THE FEEDBACK: VISUAL INSPECTION FOUND THE DEVICE TO BE FREE FROM DAMAGE OR DEBRIS WHICH COULD NEGATIVELY AFFECT THE PERFORMANCE OF THE DEVICE. THE TENSIONER WAS INSTRUMENT MILKED AND TESTED THREE TIMES IN AN INLINE CONFIGURATION IN ACCORDANCE WITH THE WORK INSTRUCTION. THE EXACT ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. NO MANUFACTURING RELATED FAILURE COULD BE FOUND. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT WEIGHT WAS NOT PROVIDED BY REPORTER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE FLUTED KNOB OF THE CABLE TENSIONER KEPT TURNING AND DID NOT TENSION THE CABLE DURING SURGERY. THE SURGEON USED ANOTHER CABLE TENSIONER TO TENSION THE CABLE AND COMPLETE THE PROCEDURE. THERE WAS 10 MINUTES DELAY IN THE SURGERY. THERE WAS NO REPORT OF PATIENT HARM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313500 CABLE TENSIONER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P112470

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR