BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 14MM WIDE

    MDR report key: 7171829 · Received January 8, 2018

    Report

    Report Number
    8030965-2018-50121
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    December 11, 2017
    Report Date
    December 11, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTD
    UDI-DI
    07611819221017
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 399.121, SYNTHES LOT NUMBER: 5902265, RELEASE TO WAREHOUSE DATE: 16.JUN.2009, MANUFACTURING SITE: (B)(4). NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION 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

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4) IS USED TO CAPTURE NO PATIENT INVOLVEMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE FORCEPS BROKE ON (B)(6) 2017. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 14MM WIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16601 BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 14MM WIDE FORCEPS HTD OBERDORF SYNTHES PRODUKTIONS GMBH 5902265 07611819221017

    Patients

    Seq Age Sex Outcome Treatment
    1