BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3971282 · Received July 31, 2014

    Report

    Report Number
    2520274-2014-12966
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR THE CABLE TENSIONER, PART AND LOT NUMBER UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    A DEVICE HISTORY REVIEW HAS BEEN CONDUCTED. THE REPORT INDICATES THAT THE PIONEER SURGICAL TECHNOLOGY MANUFACTURED THE CABLE TENSIONER, P/N 391.201, AND LOT NUMBER P081374 FOR POS 1161132, 1176092, AND 1188827. THE SUPPLIER¿S CERTIFICATES OF COMPLIANCE (DATED 9/22/10, 9/23/10, 10/18/10, AND 10/18/10 FOR FOUR SEPARATE RECEIPTS OF THIS LOT) INDICATE THE PARTS WERE MANUFACTURED TO P/N 391.201. THE PARTS WERE MADE TO THE CORRECT MATERIAL REQUIREMENTS, AND MET THE HARDNESS AND REQUIRED SPECIFICATIONS. THE LOTS WERE INSPECTED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER NS020097, REVISION ¿A¿, (DATED 9/29/10, 9/30/10, 10/22/10, AND 10/22/10). NCR 1034673 (DATED 10/26/10) WAS WRITTEN FOR THE ETCH BEING CUT-OFF ON TWO PIECES. THE TWO PIECES WERE RETURNED TO THE SUPPLIER AND THE NCR WAS CLOSED 11/17/10. THE FOUR RECEIPTS OF THIS LOT WERE RELEASED 9/29/10, 10/1/10, 10/27/10, AND 11/17/10. P/N 391.201 IS MADE FROM DRAWING, 391.201, REVISION ¿J¿, RELEASED ON JULY 27, 2010. A MANUFACTURING EVALUATION HAS BEEN CONDUCTED. THE REPORT INDICATES THAT THE CABLE TENSIONER WAS MANUFACTURED IN OCTOBER 2010 AND REVIEW OF THE DHR SHOWS NO DEVIATIONS TO SPECIFICATION. WE CANNOT DETERMINE WHY THIS ISSUE OCCURRED. HOWEVER AS A RESULT OF CUSTOMER FEEDBACK, THE DESIGN OF THIS ARTICLE WAS CHANGED COMPLETELY AND THE FIRST LOT WITH A NEW DESIGN WAS PRODUCED IN OCTOBER 2011, WITH A NEW ARTICLE NUMBER 03.221.015. 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 REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE FOR A FEMORAL SUB-TROCHANTERIC FRACTURE CASE THE CABLE (WITHOUT PLATE) TENSIONER COULD NOT APPLY TENSION MORE THAN 20KG. THE DEVICE WAS WASHED WITH SALINE TO CLEAN OF THE BLOOD AND THE SAME FAILURE OCCURRED AGAIN. THE SURGEON USED A SOFT STEEL WIRE OWNED BY THE HOSPITAL TO COMPLETE THE CASE. THE EVENT RESULTED IN A 30 MINUTE SURGICAL DELAY IT WAS REPORTED NO HARM OCCURRED TO THE PATIENT THIS REPORT IS FOR THE CABLE TENSIONER, PART AND LOT NUMBER UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446529 CABLE TENSIONER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P081374

    Patients

    Seq Age Sex Outcome Treatment
    1