BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 2.5MM HEXAGONAL SCREWDRIVER

    MDR report key: 3031810 · Received April 2, 2013

    Report

    Report Number
    2520274-2013-11054
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 14, 2012
    Report Date
    March 14, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. PRODUCT DEVELOPMENT EVALUATION REPORTS THAT THE SAMPLE WAS RECEIVED WITH THE PHENOLIC HANDLE BROKEN AND EXHIBITED SIGNS OF EXTENSIVE USE. THIS COMPLAINT IS CONSIDERED INVALID WITH RESPECT TO DESIGN. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    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.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLANNED REMOVAL OF A SCREW FROM THE ANKLE OF A PATIENT, THE HANDLE OF A 2.5MM HEXAGONAL SCREWDRIVER SPLINTERED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133905 CANNULATED 2.5MM HEXAGONAL SCREWDRIVER HXX SYNTHES USA A4CB295

    Patients

    Seq Age Sex Outcome Treatment
    1