BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.8MM DRILL BIT/QC/165MM

    MDR report key: 12289071 · Received August 6, 2021

    Report

    Report Number
    8030965-2021-06480
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    July 8, 2021
    Report Date
    July 8, 2021
    Product Code
    HTW
    UDI-DI
    07611819245891
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    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. H3, H4, H6: PART: 310.284. LOT: L930010. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 12.JUNE 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE LCP DRILL BIT Ø2.8 W/STOP L165 2FLUTE (P/N:310.284, LOT NUMBER:L930010) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, THE DISTAL TIP OF THE DRILL BIT WAS OBSERVED TO BE BROKEN. THE STOP RING WAS MISSING FROM THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. REPORTED CONDITION OF EMBEDDED DEVICE WAS NOT CONFIRMED AS NO X-RAYS WERE PROVIDED. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DOCUMENT/SPECIFICATION REVIEW: (CURRENT AND MANUFACTURED) DRILL BIT 2-FLUTE DX.X WITH STOP RING. STOP RING. DRILL BIT FOR QUICK COUPLING. DIMENSIONAL INSPECTION: SHAFT DIAMETER JUST BELOW THE FLUTES OF THE DRILL BIT: MEASURED DIMENSIONS: RESULT: CONFORMING. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT COULD BE CONFIRMED AS THE DRILL BIT WAS IDENTIFIED TO BE BROKEN. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 310.284, LOT: 59P6629, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 17 JUNE 2020, EXPIRY DATE: N/A. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021 THE DRILL BIT BROKE AND REMAINED INSIDE THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS OKAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185137 2.8MM DRILL BIT/QC/165MM BIT, DRILL HTW L930010 07611819245891

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention