BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT

    MDR report key: 3072604 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10716
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    September 27, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH 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 EVENT EVALUATION REVEALS, THE DESIGN IS ACCEPTABLE. THE PART WAS RECEIVED, AN EVALUATION IS NOT AVAILABLE. THE DESIGN IS PROVEN AND THERE IS NO INDICATION OF A DESIGN RELATED ISSUE WITH THIS COMPLAINT. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. THIS COMPLAINT IS INVALID.

    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 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 MDRA REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. (B)(4)

    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 LOT IS AVAILABLE AND A REVIEW OF THE DHR IS CURRENTLY IN PROGRESSORIGINAL AWARENESS DATE IS 9/27/11. AWARENESS DATE OF LOT NUMBER IS 10/6/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF)OF THE DISTAL FEMUR, THE TIP OF THE SCREWDRIVER BROKE OFF DURING SCREW TIGHTENING. THE TIP WAS RETRIEVED AND DISCARDED. THE SURGEON USED ANOTHER SCREWDRIVER TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173701 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT HXX SYNTHES (USA) MONUMENT 4467992

    Patients

    Seq Age Sex Outcome Treatment
    1