BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPDM QUICK-CON SI POLY SCWDRVR

    MDR report key: 11855516 · Received May 20, 2021

    Report

    Report Number
    1526439-2021-01011
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 22, 2021
    Report Date
    April 22, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HXX
    UDI-DI
    10705034198897
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. H3, H6: PART # 279712400; LOT # 0908MI; SUPPLIER: (B)(4). BATCH # 1 QTY (B)(4)- RELEASE TO WAREHOUSE DATE: 19 NOV 2008; BATCH # 2 QTY (B)(4)- RELEASE TO WAREHOUSE DATE: 15 DEC 2008; BATCH # 3 QTY (B)(4)- RELEASE TO WAREHOUSE DATE: 20 JAN 2009; BATCH # 4 QTY (B)(4)- RELEASE TO WAREHOUSE DATE: 11 FEB 2009; BATCH # 5 QTY (B)(4)- RELEASE TO WAREHOUSE DATE: 27 FEB 2009; BATCH # 6 QTY (B)(4)- RELEASE TO WAREHOUSE DATE: 27 FEB 2009; BATCH # 7 QTY (B)(4)- RELEASE TO WAREHOUSE DATE: 13 MAR 2009; BATCH # 8 QTY (B)(4)- RELEASE TO WAREHOUSE DATE: 09 APR 2009; BATCH # 9 QTY (B)(4)- RELEASE TO WAREHOUSE DATE: 16 APR 2009. NO NCR'S WERE GENERATED DURING PRODUCTION. 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. 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. 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

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE SCREW DRIVER INTERFACE STRIPPED DURING SCREW INSERTION. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM QUICK CONNECT SI POLY DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752426 XPDM QUICK-CON SI POLY SCWDRVR SCREWDRIVER HXX DEPUY SPINE INC 279712400 0908MI 10705034198897

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SCREWS| UNKNOWN SCREWS