BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSION HOLDER F/TEMP-USE

    MDR report key: 3130635 · Received May 24, 2013

    Report

    Report Number
    1719045-2013-01463
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DATES: 11/11/2010 AND 12/03/2010: ADDITIONAL INFORMATION. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # P082296 REVEALED THE PRECISION TENSIONING DEVICE WAS MANUFACTURED BY PIONEER SURGICAL TECHNOLOGIES. TWO SHIPMENTS OF THIS LOT WERE RECEIVED BY SYNTHES. PO # (B)(4) , DATED 10/28/2010, FOR 26 PARTS WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) REVISION A ON 10/29/2010. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE (C OF C) IS DATED 10/22/2010. 26 PARTS WERE RELEASED TO THE WAREHOUSE ON 11/11/2010. PO # (B)(4), DATED 12/2/2010, FOR (B)(4) PARTS WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) REVISION A ON 12/2/2010. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE (C OF C) IS DATED 11/22/2010. 65 PARTS WERE RELEASED TO THE WAREHOUSE ON 12/3/2010. THE PROVISIONAL TENSIONING DEVICES WERE RECEIVED WITH NO VISIBLE DAMAGE. PIONEER SURGICAL MANUFACTURED THE PROVISIONAL TENSIONING DEVICES, P/N 391.884, AND LOT NUMBER P082296, ON SYNTHES PURCHASE ORDERS (B)(4). PIONEER RESPONDED ON AUGUST 16, 2013 AND STATED: ALL THREE DEVICES WORK AS INTENDED. PIONEER¿S DHR REVIEW CONFIRMED THIS PRODUCT MET SPECIFICATION PRIOR TO SHIPPING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RECEIVED AND EVALUATED. A FUNCTIONAL TEST SHOWS THAT THE INSTRUMENT IS WORKING WITHOUT ANY PROBLEM. THE CAUSE IS UNKNOWN. THIS IS INDICATIVE OF FRICTION LOSS BY LUBRICATION WITH BLOOD OR BODY FLUIDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED CONFORMITY WITH THE MATERIAL- AND MANUFACTURING SPECIFICATIONS; THIS LOT WAS MANUFACTURED IN NOVEMBER 2010 AND SYNTHES IS NOT AWARE OF ANY QUALITY PROBLEMS OR FAILURES CAUSED BY A FAULTY PRODUCT. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TENSION HOLDER IS NO LONGER ABLE TO DO ITS FUNCTION AND DOES NOT ALLOW THE SURGEON TO SECURE THE CABLE AND MAINTAIN THE INITIAL TENSION. IT IS UNKNOWN WHEN OR WHERE THIS WAS DISCOVERED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232454 TENSION HOLDER F/TEMP-USE LXH SYNTHES MONUMENT P082296

    Patients

    Seq Age Sex Outcome Treatment
    1