BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM SCREWDRIVER SELF-RETAINING

    MDR report key: 2983004 · Received February 26, 2013

    Report

    Report Number
    2530088-2013-10157
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. THE DHR WAS REVIEWED. PARTS WERE 100% SCREENED, NONCONFORMING PARTS WERE SCRAPPED AND ONLY CONFORMING PARTS WERE ACCEPTED. THERE WERE NO NON-CONFORMANCES FOUND IN THE DHR THAT WERE RELATED TO THIS COMPLAINT CONDITION. THIS INSTRUMENT WAS INSPECTED 100% FOR VISUAL NON-CONFORMANCES AT THE TIME OF MANUFACTURE. THE INSTRUMENT WAS RECEIVED WITH THE HOLDING PIN MISSING FROM THE HANDLE. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE HANDLE WAS LOOSE DUE TO THE MISSING HOLDING PIN. THE PIN WAS NOT SENT ALONG WITH THE SCREW DRIVER. WE WERE NOT ABLE TO DETERMINE WHY THE PIN DID NOT HOLD.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE SURGEON DISCOVERED THAT WHILE SCREWING IN THE LAST SCREW, THE RETAINING PIN FELL OUT OF THE 2.4 MM SCREWDRIVER. THE PROCEDURE WAS COMPLETED BY MANUALLY PUTTING IN THE SCREW. NO HARM WAS REPORTED TO THE PT AND ALL PARTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81507 2.4MM SCREWDRIVER SELF-RETAINING HXX SYNTHES (USA) BRANDYWINE A4HA167

    Patients

    Seq Age Sex Outcome Treatment
    1