BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3311432 · Received August 27, 2013

    Report

    Report Number
    1719045-2013-01905
    Event Type
    Malfunction
    Date Received
    August 27, 2013
    Report Date
    July 29, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE RESULTS OF THE MANUFACTURING EVALUATION ARE AS FOLLOWS: PIONEER SURGICAL MANUFACTURED THE CABLE TENSIONER, P/N 391.201, AND LOT NUMBER P056866, ON SYNTHES PURCHASE ORDERS (B)(4). PIONEER RESPONDED ON SEPTEMBER 20, 2013 AND STATED THAT ¿FUNCTIONAL INSPECTION DETERMINED THAT THE DEVICE DID NOT MEET SPECIFICATION. IT WAS EVIDENT THAT THE DEVICE CONTAINED LOOSE COMPONENTS INTERNALLY. DESTRUCTIVE TESTING FOUND THAT THE COLLET TIPS BECAME DISASSOCIATED FROM THE COLLET ASSEMBLY. ALL CRITICAL DIMENSIONS WERE TAKEN ON THE COMPONENTS WITHIN THE ASSEMBLY. ALL DIMENSIONS MET SPECIFICATION.¿ PIONEER ALSO NOTED THAT THE OVERALL LENGTH OF THE SPRING DID NOT MEET SPECIFICATIONS DUE TO THE COMPRESSION OF THE SPRING DURING ASSEMBLY. PIONEER¿S DHR REVIEW ¿CONFIRMED THIS PRODUCT MET SPECIFICATION PRIOR TO SHIPPING.¿ BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY PIONEER SURGICAL AND SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS (B)(4) MANUFACTURED THE CABLE TENSIONER, P/N 391.201, AND LOT NUMBER P056866 ON SYNTHES PURCHASE ORDERS 1140077, 1140717, 1128961, AND 1161132. THE SUPPLIERS CERTIFICATES OF COMPLIANCE (DATED 5/24/10, 6/15/10, AND 6/15/10 FOR THE FIRST THREE RECEIPTS OF THIS LOT ¿ THE CERT WAS NOT INCLUDED IN THE DHR FOR THE 4TH RECEIPT OF THIS LOT) INDICATE THE PARTS WERE MANUFACTURED TO P/N 391.201 AND MET THE REQUIRED SPECIFICATIONS. THE 1ST AND 4TH RECEIPTS OF THIS LOT WERE NOT REQUIRED TO BE INSPECTED. THE 2ND AND 3RD RECEIPTS WERE INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER 391IF201, REVISION H, COMPLETED JUNE 21, 2010 FOR BOTH RECEIPTS. THERE WERE NO MRRS, NCRS, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. THE FOUR RECEIPTS OF THIS LOT WERE RELEASED 6/4/10, 6/22/10, 6/22/10, AND 6/30/10.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(4) AS FOLLOWS: A CABLE TENSIONER HEAD BROKE. THE CABLE TENSIONER CAME BACK FROM THE CUSTOMER FOR SERVICE, BUT UNFORTUNATELY THEY COULD NOT FIX IT. THE FLUTED KNOB ON THE CABLE TENSIONER MOVES FREELY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420589 CABLE TENSIONER LXH SYNTHES MONUMENT P056866

    Patients

    Seq Age Sex Outcome Treatment
    1