BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 2960561 · Received February 14, 2013

    Report

    Report Number
    1719045-2013-00316
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 28, 2012
    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

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THERE WERE SIX PURCHASE ORDERS WITH THIS DHR REVIEW. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH ANY OF THE SIX ORDERS. THE CABLE TENSIONER WAS MADE TO THE SYNTHES DRAWING RELEASED ON (B)(4) 2010.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. UPON INITIAL INVESTIGATION THE TENSIONER WAS TESTED THREE TIMES. ON THE THIRD ATTEMPT, THE TENSIONER WAS UNABLE TO REACH ADEQUATE TENSION. UPON DISASSEMBLY OF THE TENSIONING DEVICE, THERE WAS NO EVIDENCE OF BROKEN COMPONENTS OR DEBRIS THAT MAY HAVE AFFECTED THE PERFORMANCE OF THE DEVICE. THE ONLY SIGNIFICANT WEAR WAS FOUND ON THE COLLET TIPS USING MAGNIFICATION. DIMENSIONAL INSPECTION WAS PERFORMED ON CERTAIN FEATURES OF THE COLLET TIP AND ON MATING COMPONENTS. THE MEASURED VALUES MET SPECIFICATION. DHR REVIEW DETERMINED THIS DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO DEFINITIVE MANUFACTURING ROOT CAUSE COULD BE DETERMINED. HOWEVER THE FOLLOWING HYPOTHESES MAY BE LIKELY: WEAR ON THE COLLET TIP REDUCED THE CLAMPING FORCE REQUIRED TO SECURE THE CABLE IN ORDER TO APPLY ADEQUATE TENSION; DEBRIS WAS LODGED WITHIN THE COLLET TIP ASSEMBLY THAT WAS NOT NOTICED UPON DISASSEMBLY.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY THE CABLE TENSIONER DEVICE DOES NOT WORK AT ALL. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. THIS IS REPORT 1 OF 1 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64187 CABLE TENSIONER TENSIONER LXH SYNTHES MONUMENT P079532

    Patients

    Seq Age Sex Outcome Treatment
    1