BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILLCHUCK DRILLING SPEED W/KEY F/TRS CL

    MDR report key: 3011917 · Received March 19, 2013

    Report

    Report Number
    2520274-2013-01554
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE OILY, WHITE SUBSTANCE WAS EVALUATED BY BIOSERVICE SCIENTIFIC LABORATORIES IN (B)(4) WITH THE FOLLOWING RESULTS: UNDER THE CONDITIONS OF THE PRESENT STUDY IT CAN BE STATED THAT THE POLAR EXTRACT OF THE TEST ITEM CAUSED NO SIGNS OF IRRITATION. UNDER THE DONCITIONS OF THE PRESENT STUDY IT CAN BE STATED THAT THE NONPOLAR EXTRACT OF THE TEST ITEM CAUSED SIGNS OF IRRITATION. THE PRIMARY IRRITATION INDEX FOR THE NONPOLAR TEST ITEM EXTRACT COMPARED TO THE NONPOLAR REAGENT CONTROL WAS 0.2. AS THE PRIMARY IRRITATION INDEX FOR BOTH TEST ITEM EXTRACTS WAS LESS THAN 1, THE REQUIREMENTS OF THE TEST ARE MET AND THE TEST ITEM IS CLASSIFIED AS NOT IRRITANT. DEVICE MANUFACTURE DATE: SHOULD BE (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THIS IS 2 OF 4 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2013 AN OILY WHITE RESIDUE WAS FOUND ON END OF THE TRS ATTACHMENTS AND SPLATTERED INSIDE OF THE STERILIZING PAPER, POST THE STERILIZATION PROCESS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 2 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113163 DRILLCHUCK DRILLING SPEED W/KEY F/TRS CL HWE SYNTHES GMBH 5561

    Patients

    Seq Age Sex Outcome Treatment
    1