BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS W/SERRATED JAW-MEDIUM HANDLE-SOFT RATCHET

    MDR report key: 5869713 · Received August 11, 2016

    Report

    Report Number
    3009417901-2016-10026
    Event Type
    Malfunction
    Date Received
    August 11, 2016
    Date of Event
    July 25, 2016
    Report Date
    July 25, 2016
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED/PERFORMED. THE REPORT INDICATES THAT THE: ARTICLE 399.098 LOT 5934351 HAS BEEN MANUFACTURED IN (B)(4) WITH WORK ORDER (B)(4) ON 02-JUN -2015. PRODUCT INSPECTION: THE PART RETURNED HAS BEEN RE-INSPECTED FOR ALL THE FEATURES PERTINENT TO COMPLAINT CONDITION. THE REVIEW OF THE DHR SHOWS NO NON CONFORMITIES. THE 100% INSPECTION OF THE LOCKING MECHANISM IS DOCUMENTED IN INSPECTION. IN THE PERIOD OF 01-AUG-2014, TILL 18-AUG-2016, (B)(4) OF ARTICLE 399.098 HAVE BEEN MANUFACTURED. THIS COMPLAINT IS THE ONLY ONE IN THE SAME PERIOD. THE PERFORMED FUNCTIONAL INSPECTION SHOWS THAT THE SPRING OF THE FORCEPS IS BROKEN AND THE LOCKING MECHANISM DOES NOT WORK. THIS COMPLAINT IS CONFIRMED. DEVICE 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JUNE 05, 2015. NO DEVIATION LISTED IN THE DEVICE HISTORY RECORD. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE FORCEPS BROKE AFTER COMPLETION OF THE STERILIZATION CYCLE OF THE INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522366 REDUCTION FORCEPS W/SERRATED JAW-MEDIUM HANDLE-SOFT RATCHET FORCEPS HTD SYNTHES SALZBURG 5934351

    Patients

    Seq Age Sex Outcome Treatment
    1