BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION WRENCH Ø11

    MDR report key: 3191539 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03273
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    July 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. THE DHR WAS REVIEWED AND THE RECORD INDICATES THE PARTS WERE MANUFACTURED IN CONFORMANCE WITH SYNTHES SPECIFICATIONS. THE PRODUCT INVESTIGATION AND VISUAL INSPECTION DID NOT SHOW ANY DISCREPANCIES FROM THE SPECIFICATION. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. SOME CORROSION ON THE SURFACE OF THE DEVICE WAS EVIDENT AND DETERMINED TO BE A RESULT OF INCORRECT CLEANING AND STORAGE AND NOT ANY DEFECT OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CORROSION ON THE 11 MM COMBINATION WRENCH, PART NUMBER 321.160. THE CORROSION MADE THE TOOL UNAVAILABLE FOR USE. THERE WAS NO ILL EFFECT ON ANY PATIENT OR EXTENSION OF SURGERY TIME AS A RESULT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290314 COMBINATION WRENCH Ø11 MNI SYNTHES GMBH 3632593

    Patients

    Seq Age Sex Outcome Treatment
    1