BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 4148036 · Received October 7, 2014

    Report

    Report Number
    2520274-2014-13949
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Report Date
    September 11, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A SERVICE EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE CUSTOMER REPORTED THE BOTTOM TIP WAS MISSING. THE REPAIR TECHNICIAN REPORTED ¿DAMAGED COMPONENT¿ AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR ON OCT 10, 2014. THIS ITEM PASSED SYNTHES FINAL INSPECTION ON DECEMBER 12, 2014. THE COMPLAINT CONDITION WAS CONFIRMED. SINCE THE LOT NUMBER OF THE SUBJECT DEVICE WAS IDENTIFIED, A SECOND SERVICE HISTORY REVIEW WAS REQUESTED. : SUBJECT DEVICE WAS RECEIVED ON SEP 29, 2014. 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

    ADDITIONAL NARRATIVE: SERVICE HISTORY REVIEW: SERVICE HISTORY REVIEW: LOT #P505400 (UPDATED) NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 10-MAY-2001. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. SERVICE EVALUATION: THE COMPONENT WAS REPAIRED AND TESTED TO OPERATIONAL SPECIFICATIONS AND RETURNED TO THE CUSTOMER. NO CAUSE WAS OBSERVED; NO MANUFACTURING OR DESIGN ISSUES WERE NOTED. 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 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED 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

    IT WAS REPORTED THE CABLE TENSIONER IS MISSING THE BOTTOM TIP OF INSTRUMENT. IT IS UNKNOWN WHEN THE INSTRUMENT WAS FOUND TO BE MISSING THE TIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628797 CABLE TENSIONER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P505400

    Patients

    Seq Age Sex Outcome Treatment
    1