BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/CFN/AFN F/SYNREAM

    MDR report key: 3139464 · Received May 31, 2013

    Report

    Report Number
    2520274-2013-03000
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    February 7, 2011
    Report Date
    February 17, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THE MEASURABLE DIMENSIONS OF THE BROKEN CONNECTING SCREW WERE CHECKED, AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE CONNECTING SCREW WAS MANUFACTURED IN FEBRUARY 2003. NO PRODUCT FAULT COULD BE DETECTED. WE CAN ONLY ASSUME THAT THERE WAS A TECHNICAL COMPLICATION DURING SURGERY WHICH CAUSED THE BREAKAGE; PROBABLY THE CONNECTING SCREW WAS NOT COMPLETELY SECURED TO THE NAIL. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    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)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THE NAIL, WHILE HAMMERING ON THE INSERTION HANDLE, THE CONNECTION SCREW BROKE OFF IN THE NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241322 CONNECSCR F/CFN/AFN F/SYNREAM HWC SYNTHES USA 2041428

    Patients

    Seq Age Sex Outcome Treatment
    1