BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK

    MDR report key: 5691126 · Received June 1, 2016

    Report

    Report Number
    2520274-2016-12954
    Event Type
    Malfunction
    Date Received
    June 1, 2016
    Report Date
    May 10, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INFORMATION ALREADY ON MAUDE REPORT: INITIAL COMPLAINT DESCRIPTION, CATALOG NUMBER, CONTACT AND ESTABLISHMENT NAME. CORRECTION TO INFORMATION FROM MAUDE REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS AGAINST MAUDE REPORT NUMBERS 5061738 AND 5061739. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THE SCREWS THAT BROKE DURING THE REVISION WERE NOT SCREWS THAT HAD BEEN IMPLANTED IN A PREVIOUS SURGERY, BUT RATHER NEW SCREWS THAT BROKE AS THEY WERE BEING IMPLANTED. IT IS UNKNOWN WHAT MANUFACTURED PRODUCT THE PATIENT WAS IMPLANTED WITH. IT IS ALSO UNKNOWN IF ANY OF THE HARDWARE WAS REMOVED DURING THE PROCEDURE. CONCOMITANT DEVICES REPORTED: UNKNOWN IMPLANT DEVICES (PART # UNKNOWN, LOT #, UNKNOWN, QUANTITY # UNKNOWN) THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347191 REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK FORCEPS HTD SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR UNKNOWN IMPLANT DEVICES