BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    MDR report key: 3070646 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10936
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    October 2, 2011
    Report Date
    October 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE DEVICE WAS IN SINGLE PARTS WHEN RECEIVED. THE SETTING SCREW WHICH HOLDS THE CONNECTOR TOGETHER IS LOOSE, THEREFORE THE DEVICE FELL APART. THE DEVICE MEETS THE SPECIFICATIONS, REASSEMBLING IS POSSIBLE. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLEXIBLE SHAFT CONNECTOR FELL APART WHILE REAMING A PATIENT. ANOTHER WAS SELECTED AND THE PROCEDURE WAS COMPLETED. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172637 FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK HTO SYNTHES GMBH 2400775

    Patients

    Seq Age Sex Outcome Treatment
    1