BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HOHMANN RETRACTOR 6MM SHORT NARROW TIP 160MM

    MDR report key: 3013491 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-10551
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4). ORIGINAL AWARENESS DATE IS (B)(6) 2012. PLACEHOLDER.

    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 DEVICE HISTORY RECORD WAS NOT AVAILABLE AS INSTRUMENT IS NEARLY 10 YEARS OLD. THE MANUFACTURING VISUAL EVALUATION NOTED THAT THE WHOLE INSTRUMENT IS DISCOLORED. THE RETRACTOR CORRESPONDS TO THE DRAWING AND PROCESSES AT THE TIME OF MANUFACTURE. THE RETRACTOR IS 10 YEARS OLD AND IT SEEMED AS IT WAS NOT CLEANED PROPERLY.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ACCOUNT COMPLAINED TO THE SALES CONSULTANT THAT THE INSTRUMENTS ARE RUSTING AROUND THE ETCH. THIS IS 4 OF 6 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116539 SMALL HOHMANN RETRACTOR 6MM SHORT NARROW TIP 160MM GAD SYNTHES GMBH A7 LA 22

    Patients

    Seq Age Sex Outcome Treatment
    1