BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

    MDR report key: 3962463 · Received July 29, 2014

    Report

    Report Number
    9680938-2014-10043
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SERVICE HISTORY REVIEW: LOT T933354: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE SERVICE HISTORY RECORDS HAS BEEN REQUESTED 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

    IT WAS REPORTED THAT A PIECE OF THE END OF THE REDUCTION FORCEPS WITH POINTS BROAD-RATCHET IS BROKEN OFF, IT IS UNCERTAIN OF WHEN THE END WAS BROKEN AND REPORTEDLY HAS BEEN BROKEN FOR SOME TIME. NO PATIENT WAS INVOLVED IN THIS EVENT. THE DEVICE WAS DISCARDED BY THE FACILITY THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442544 REDUCTION FORCEPS WITH POINTS BROAD-RATCHET FORCEPS HTD SYNTHES TUTTLINGEN T933354

    Patients

    Seq Age Sex Outcome Treatment
    1