BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP F/ILIAC CONNECTOR F/FIXED-L

    MDR report key: 3193370 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03352
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    August 31, 2011
    Report Date
    September 8, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE MEASUREABLE DIMENSIONS OF THE CLAMP WHICH WAS SENT IN WAS EXAMINED. IT REVEALED THAT IT COMPLIED WITH THE DRAWINGS AND SPECIFICATIONS. THE INVESTIGATION OF THE RAW MATERIAL TEST CERTIFICATE AND THE MANUFACTURE DOCUMENTS SHOWED THAT THERE WERE NO DISCREPANCIES IN TERMS OF THE MATERIAL ANALYSIS, TENSILE STRENGTH, AND THE STRUCTURAL STABILITY AS WELL AS THE FABRICATION. THE EXACT CAUSE OF THE PROBLEM COULD NOT BE DETERMINED. THE BREAKAGE ITSELF IS HOMOGENOUS WHICH POINTS TO A FLAWLESS MATERIAL QUALITY. WE CAN ONLY ASSUME THAT THE CLAMP BROKE DUE TO AN OVERLOAD DURING THE FINAL FASTENING. THERE WERE NO PRODUCT DEFECTS DETERMINED.

    Description of Event or Problem · 1

    IT WSS REPORTED THAT THE CLAMP BROKE OFF DURING FINAL TIGHTENING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291902 CLAMP F/ILIAC CONNECTOR F/FIXED-L NKB SYNTHES GMBH 3699516

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR