BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 4152244 · Received October 8, 2014

    Report

    Report Number
    1719045-2014-10497
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE TENSIONER WAS STICKY. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. SERVICE HISTORY REVIEW: LOT P015544: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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 MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT (B)(4) MANUFACTURED THE CABLE TENSIONER, P/N 391.201, AND LOT #P015544 ON PO #879453, FOR 4 PIECES DELIVERED MAY 14, 2008, ON PO #864635 FOR 21 PIECES DELIVERED MAY 14, 2008, ON PO #864635 FOR 14 PIECES DELIVERED MAY 22, 2008 AND ON PO #874160 FOR 10 PIECES DELIVERED MAY 22, 2008. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED MAY 13, 2008 (FOR THE MAY 14 DELIVERIES), MAY 21, 2008 (FOR THE MAY 22 DELIVERIES), AND SYNTHES FINAL INSPECTION SHEET #391IF201, REVISION ¿H¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON MAY 14, 2008 (4 PIECES), ON MAY 15, 2008 (21 PIECES) AND ON MAY 28, 2008 (14 PIECES AND 10 PIECES). THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE CABLE TENSIONER WAS MADE TO THE SYNTHES DRAWING P/N 391.201, REVISION ¿H¿, RELEASED ON DECEMBER 14, 2006. DUE TO AN UNKNOWN CAUSE, THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT THE CABLE TENSIONER (391.201) IS STICKY. COMPLAINT ISSUE WAS DISCOVERED DURING A CASE. REPORTEDLY, THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH THE CABLE TENSIONER WITHOUT ISSUES. THE SUPPLIER REPORTED THAT UPON RECEIPT, ¿VISUAL INSPECTION FOUND NO FAILURES.¿ SUPPLIER STATED, ¿FUNCTIONAL INSPECTION COULD NOT DUPLICATE ¿STICKY¿ OPERATION. DIMENSIONAL INSPECTION PASSED PER SPEC WITH MEASUREMENTS OF 40.6KG, 40.2KG AND 40.2KG. A MANUFACTURING ROOT CAUSE COULD NOT BE DETERMINED. A DHR REVIEW WAS CONDUCTED AND FOUND THAT THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPPING.¿ BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS UNCONFIRMED AND IS NOT CONSIDERED MANUFACTURING-RELATED. 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.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 THAT THE CABLE TENSIONER IS STICKY. COMPLAINT ISSUE WAS DISCOVERED DURING A CASE. REPORTEDLY, THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH THE CABLE TENSIONER WITHOUT ISSUES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE EVENT RESULTED IN NO SURGICAL DELAY AND PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT OTHER MEDICAL INTERVENTION REQUIRED. ADDITIONALLY THERE WERE NO FRAGMENTS OR RETAINED HARDWARE DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631285 CABLE TENSIONER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P015544

    Patients

    Seq Age Sex Outcome Treatment
    1