BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTACHMENT BIT

    MDR report key: 4587765 · Received March 10, 2015

    Report

    Report Number
    2520274-2015-11642
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Date of Event
    February 25, 2015
    Report Date
    February 25, 2015
    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

    ADDITIONAL MANUFACTURING RELEASE DATE FOR THIS PRODUCT WAS (B)(6) 2008. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW: PIONEER SURGICAL (PRESENTLY RTI SURGICAL) MANUFACTURED THE ATTACHMENT BIT (PART NUMBER 391.883, LOT NUMBER P031515). THE SUPPLIER¿S CERTIFICATES OF CONFORMANCE INDICATES THAT THE PARTS MET ALL REQUIRED SPECIFICATIONS. NO MATERIAL RECORD REPORTS OR NON-CONFORMANCE REPORTS WERE GENERATED FOR THIS LOT AND THE TWO RECEIPTS WERE RELEASED (B)(6) 2008 AND (B)(6) 2008. 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. NO PATIENT DATA REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND 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.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE PASSED VISUAL AND FUNCTION INSPECTION. THE CABLE FREELY PASSES THROUGH THE ATTACHMENT BIT. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND FOUND THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. A ROOT CAUSE COULD NOT BE DETERMINED AS 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.

    Description of Event or Problem · 1

    DEVICE REPORTS FROM SYNTHES (B)(4) REPORTED THE EVENT FROM (B)(6).

    Description of Event or Problem · 1

    THE FLUTED KNOB ON THE REPORTED CABLE TENSIONER KEPT TURNING IDLE AND NEVER REACHED THE DESIRED TENSION. THE TENSION OF THE CABLE TENSIONER SOMETIMES REACHED AROUND 20 KG. EVENTUALLY, THE SURGEON TIGHTENED CERCLAGE CABLE BY THE FORCE. THERE WAS 15 MINUTES DELAY IN THE SURGERY. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163517 ATTACHMENT BIT MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P031515

    Patients

    Seq Age Sex Outcome Treatment
    1