BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSION HOLDER F/TEMP-USE

    MDR report key: 3251456 · Received July 29, 2013

    Report

    Report Number
    1719045-2013-01855
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    April 5, 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. THE COMPLAINED DEVICE WAS EVALUATED BY THE SYNTHES (B)(4) PRODUCT DEVELOPMENT CENTRE AND THE REPORT STATES THE FOLLOWING: THE INVESTIGATION OF THE COMPLAINED TENSION HOLDER SHOWS, THAT THE ARTICLE FULLY COMPLIES WITH THE SPECIFICATION. OUR PRODUCT DEVELOPMENT CENTER REVIEWED THE PRESENT ARTICLE WITH A FUNCTIONAL TEST WITH ALL TYPES OF CABLES. IT WAS DETERMINED THE DEVICE WAS FUNCTIONING AS INTENDED. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF BLOOD OR BODY FLUID DURING THE OPERATION OR INCORRECT HANDLING. IN CONCLUSION, NO PRODUCT FAULT COULD BE DETECTED. FURTHER, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) STATED THE FOLLOWING: PIONEER SURGICAL TECHNOLOGY MANUFACTURED THE PROVISIONAL TENSIONING DEVICE, P/N 391.884, AND LOT NUMBER P120236. THE SUPPLIER¿S CERTIFICATES OF COMPLIANCE (DATED (B)(4) 2012 FOR TWO SEPARATE RECEIPTS OF THIS LOT) INDICATE THE PARTS WERE MANUFACTURED TO P/N 391.884 AND MET THE REQUIRED SPECIFICATIONS. THE LOTS WERE INSPECTED AND CONFORMED TO SYNTHES INCOMING FINAL INSPECTION REQUIREMENTS (COMPLETED (B)(4) 2012). THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. THE TWO RECEIPTS OF THIS LOT WERE RELEASED (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PIONEER SURGICAL MANUFACTURED THE PROVISIONAL TENSIONING DEVICES, P/N 391.884, AND LOT NUMBER P120236, ON SYNTHES PURCHASE ORDERS 1358837 AND 1394595. PIONEER RESPONDED ON AUGUST 16, 2013 AND STATED THAT ALL THREE DEVICES DID NOT CONTAIN DAMAGE THAT COULD HAVE NEGATIVELY AFFECTED THEIR PERFORMANCE; HOWEVER, ALL THREE DEVICES WERE MISSING THE CANTED COIL SPRING. 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 INVALID FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE, ON AN UNKNOWN DATE, THE POWER HOLDERS COULD NOT BE CLOSED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 3 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353294 TENSION HOLDER F/TEMP-USE LXH SYNTHES MONUMENT P120236

    Patients

    Seq Age Sex Outcome Treatment
    1