BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.25MM SLOTTED SCREWDRIVER BLDHEX COUPLING

    MDR report key: 3000781 · Received March 12, 2013

    Report

    Report Number
    1719045-2013-10295
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    July 5, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON WAS ATTEMPTING TO REPOSITION A PLATE AND THE TIPS OF THE SCREWDRIVER BLADES FROM THE SCREW REMOVAL SET BROKE. IT WAS REPORTED THAT ALL OF THE PIECES WERE RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103146 0.25MM SLOTTED SCREWDRIVER BLDHEX COUPLING HXX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1