BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRONT CUTTER

    MDR report key: 3171645 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02795
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    February 20, 2012
    Report Date
    February 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. THE DEVICE HISTORY RECORD REPORTS THE COMPLAINT TO BE INDETERMINATE. PER SOURCE DOCUMENT. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING DOCUMENTS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO-ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. WE ARE NOT AWARE OF ANY OTHER SIMILAR REPORTS RELATED TO THIS ARTICLE AND LOT NUMBER. PLACEHOLDER.

    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. (B)(6). THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING DOCUMENTS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. SYNTHES IS NOT AWARE OF ANY OTHER SIMILAR REPORTS RELATED TO THIS ARTICLE AND LOT NUMBER. THE SURFACES OF THE CROSS-SECTIONS ARE HOMOGENOUS; NO ANOMALIES OF MATERIALS STRUCTURE WERE FOUND. THE COMPLAINT STATISTIC OF THIS ARTICLE DOES NOT SHOW AN INCREASED BREAKAGE RATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2012, THE FRONT CUTTER WAS USED TO CUT A 1.1MM CERCLAGE WIRE. REPORTEDLY, THE CUTTER END WAS BROKEN AND RUST WAS FOUND AT THE CRACKED AREA. IT IS SUSPECTED THE CUTTER WAS WEAKENED DUE TO RUST DEVELOPED AROUND THE AREA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272858 FRONT CUTTER HXZ SYNTHES GMBH 3571701

    Patients

    Seq Age Sex Outcome Treatment
    1