BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CABLE TENSIONER

    MDR report key: 4316766 · Received December 10, 2014

    Report

    Report Number
    1719045-2014-10669
    Event Type
    Injury
    Date Received
    December 10, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 11, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING RELEASE DATE: MARCH 5, 2002. THE DEVICE HISTORY REVIEW REPORTED: PIONEER SURGICAL TECHNOLOGY MANUFACTURED THE CABLE TENSIONER, PART #391.201, AND LOT #P507758 ON PO #275263, FOR 85 PIECES DELIVERED FEBRUARY 19, 2002, AND FOR 15 PIECES DELIVERED FEBRUARY 21, 2002. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED FEBRUARY 14, 2002 (85 PIECES) AND FEBRUARY 18, 2002 (15 PIECES), AND TO SYNTHES FINAL INSPECTION SHEET #391IF201, REVISION ¿D¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON FEBRUARY 21, 2002 (85 PIECES) AND MARCH 5, 2002 (15 PIECES). THERE WAS NO MATERIAL REVIEW REPORTS, NONCONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE CABLE TENSIONER WAS MADE TO THE SYNTHES DRAWING P/N 391.201, REVISION ¿E¿, RELEASED ON NOVEMBER 8, 2001. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS CONDUCTED/PERFORMED AND THE REPORT INDICATES THAT: 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 ¿E¿, RELEASED ON NOVEMBER 8, 2001. DUE TO AN UNKNOWN CAUSE, IT WAS REPORTED THE TROCHANTERIC REATTACHMENT FAILED TO HOLD DURING SURGERY (CABLE SET WAS USED). A CERCLAGE WIRE WAS USED AS AN ALTERNATE. THE SUPPLIER REPORTED THAT UPON RECEIPT, ¿VISUAL INSPECTION FOUND THE DEVICE FREE FROM DAMAGE OR DEBRIS WHICH COULD NEGATIVELY AFFECT THE PERFORMANCE OF THE DEVICE.¿ SUPPLIER STATED, ¿THE TENSIONER WAS TESTED THREE TIMES¿ALL TEST RESULTS MEET SPECIFICATIONS. THE DHR REVIEW CONFIRMED THIS PRODUCT MET SPECIFICATION PRIOR TO SHIPPING. A MANUFACTURING ROOT CAUSE COULD NOT BE DETERMINED. UPON EVALUATION, THE DEVICE FUNCTIONED AS INTENDED.¿ 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TROCHANTERIC REATTACHMENT FAILED TO HOLD DURING SURGERY (CABLE SET WAS USED). A CERCLAGE WIRE WAS USED AS AN ALTERNATE. THE PATIENT STATUS OUTCOME IS UNKNOWN. THERE WAS A LESS THAN DESIRABLE TREATMENT OUTCOME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE EVENT RESULTED IN A GREATER THAN A 30 MINUTE DELAY. THIS IS REPORT 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802927 CABLE TENSIONER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P507758

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention