BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 9617217 · Received January 22, 2020

    Report

    Report Number
    8030965-2020-00547
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    December 28, 2019
    Report Date
    December 31, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819065154
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. E1: REPORTER IS A SYNTHES EMPLOYEE. H3, H4, H6: PART: 314.050, LOT: 3201859, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 01. JULY 2009. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. ENGINEERS ASSESSMENT: AS CAN BE SEEN FROM THE PHOTOGRAPHS, THE HEX TIGHTENING AREA OF THE CANNULATED SCREWDRIVER IS WORN, BURRED AND IS SHOWING A SMALL CRACK. THE LOT I/D IS 3201859. THIS COMPLAINT IS DUE TO WEAR AND TEAR. THE INSTRUMENT WILL BE DISPOSED OF. 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

    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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, WHEN ATTEMPTING TO USE THE CANNULATED SCREWDRIVER, IT DID NOT PROPERLY FIT OVER THE WIRE. ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. CONCOMITANT DEVICES REPORTED: UNKNOWN WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82043 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SCREWDRIVER HXX OBERDORF SYNTHES PRODUKTIONS GMBH 3201859 07611819065154

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - WIRE: TRAUMA