BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT CUTTING HEAD Ø5 LONG CUTTING-H 4 F/

    MDR report key: 3173887 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03501
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    September 23, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. THE EVALUATION REVEALED THAT THE CUTTING HEAD CANNOT BE REMOVED. THE JAMMED SCHANZ SCREWS COULD BE REMOVED FROM THE CUTTING HEAD. A VISUAL INSPECTION OF THE END OF THE SHAFT OF THE SCHANZ SCREW SHOW THAT THE CUTTING HEAD WAS NOT COMPLETELY SCREWED TOGETHER. THIS MAY LEAD TO THE JAMMING OF THE SCHANZ SCREWS. IN THE FUNCTION CHECK, TWO ADDITIONAL SCHANZ SCREWS WERE SUCCESSFULLY REMOVED FROM THE CUTTING HEAD AT HAND. NO PRODUCT DEFECTS WERE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW IS JAMMED UP IN THE BOLT CUTTERS HEAD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274400 BOLT CUTTING HEAD Ø5 LONG CUTTING-H 4 F/ HXZ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1