BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL-ATTACHM MINI-QUICK-COUPL F/EPD+APD

    MDR report key: 3195222 · Received June 28, 2013

    Report

    Report Number
    8030965-2013-03220
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    August 20, 2012
    Report Date
    August 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. ADDITIONAL PRODUCT CODES: DZI, ERL, HBE. (B)(6). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE FINDINGS INDICATE THAT THE DRILL ATTACHMENT WAS EXPOSED TO MECHANICAL OVERLOADING. UNFORTUNATELY THE EXACT CAUSE FOR THE DAMAGE COULD NOT BE DETERMINED. A MATERIAL OR MANUFACTURING ERROR CANNOT BE RULED OUT. THE DRILL ATTACHMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    DRILL ATTACHMENT FELL APART DURING SURGERY. THIS IS 1 OF 1 REPORT FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296449 DRILL-ATTACHM MINI-QUICK-COUPL F/EPD+APD HWE SYNTHES GMBH 7518853

    Patients

    Seq Age Sex Outcome Treatment
    1