BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 10896228 · Received November 24, 2020

    Report

    Report Number
    8030965-2020-09174
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Report Date
    October 29, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    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. CUSTOMER QUALITY INVESTIGATION: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THE FOLLOWING INVESTIGATION IS BASED ON THE IMAGE(S) PROVIDED. THE IMAGE WAS REVIEWED, AND THE COMPLAINT CONDITION COULD NOT BE CONFIRMED AS THE IMAGE IS NOT CLEAR AND DOES NOT SHOW ANY SIGNS OF BROKEN. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION AND A FUNCTIONAL TEST WERE NOT ABLE TO BE PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT PART NUMBER: 314.050, LOT NUMBER: 8962052, MANUFACTURING SITE: HAEGENDORF, RELEASE TO WAREHOUSE DATE: JUNE 12, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. 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 UNKNOWN DATE THAT THE SCREWDRIVER BROKE AT THE TIP WHEN THE LAST SCREW OF THE PROCEDURE WAS BEING PUT INTO PLACE WITHOUT CAUSING HARM TO THE PATIENT. THIS REPORT IS FOR ONE 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
    1355242 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SCREWDRIVER HXX SYNTHES GMBH 8962052

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWS: TRAUMA