BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 7MM WIDE

    MDR report key: 8016163 · Received October 29, 2018

    Report

    Report Number
    8030965-2018-57733
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Report Date
    October 15, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTD
    UDI-DI
    07611819220881
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. REPORTER FACILITY ADDRESSA DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 399.081 LOT: 5914496 MANUFACTURING SITE: SALZBURG RELEASE TO WAREHOUSE DATE: 11.JAN.2012 THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 27 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COUNTRY CODE 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN (B)(6) 2018, THE LOCKING MECHANISM OF A BONE HOLDING FORCEPS WAS FOUND TO BE BROKEN. THERE IS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A BONE HOLDING FORCEPS-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853235 BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 7MM WIDE FORCEPS HTD OBERDORF SYNTHES PRODUKTIONS GMBH 5914496 07611819220881

    Patients

    Seq Age Sex Outcome Treatment
    1