BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRETIGHTENER

    MDR report key: 3151308 · Received June 7, 2013

    Report

    Report Number
    8030965-2013-02807
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INVESTIGATION REPORT INDICATES THAT NO ABNORMAL FINDINGS WERE IDENTIFIED WITH THIS DEVICE. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE WIRE TIGHTENERS. A FUNCTION TEST WAS PERFORMED AND THE WIRE TIGHTENERS WERE ABLE TO APPLY THE CORRECT TENSION OF 50, 100 AND 130 KG ON A 1.8 MM AND 2.00 MM WIRE. BASED ON THESE FINDINGS, IT WAS CONCLUDED THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES AND NO PRODUCT FAULT COULD BE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED EVENT OR CAUSE OF FAILURE.

    Description of Event or Problem · 1

    THIS DEVICE, WIRE TIGHTENERS, DID NOT GIVE ADEQUATE TENSION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253552 WIRETIGHTENER LXH SYNTHES GMBH 3309426

    Patients

    Seq Age Sex Outcome Treatment
    1