BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø2.5 L110/85 2FLUTE F/QC

    MDR report key: 12738861 · Received November 2, 2021

    Report

    Report Number
    8030965-2021-09204
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    October 6, 2021
    Report Date
    October 6, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819018631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: VISUAL INSPECTION: THE DRILL BIT Ø2.5 L110/85 2FLUTE F/QC (P/N: 310.250, LOT NUMBER: 92P2822) WAS RECEIVED AT JUAREZ PAL. VISUAL EXAMINATION OF THE RETURNED DRILL BIT FOUND THE DEVICE HAS BROKEN. THE BROKEN FRAGMENTS WERE NOT RETURNED. NO EVIDENCE OF THE FRAGMENTS LEFT IN PATIENT WAS PROVIDED. NO OTHER PRODUCT DEFECTS WERE IDENTIFIED. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? EXAMINATION OF THE RETURNED DEVICE FOUND THE DRILL BIT HAS BROKEN. THE INVESTIGATION HAS FOUND SUFFICIENT EVIDENCE TO CONFIRM THE REPORTED EVENT. NO EVIDENCE OF THE BROKEN FRAGMENTS OF THE DRILL BIT BEING LEFT INSIDE THE PATIENT WAS PROVIDED. THEREFORE, THE INVESTIGATION CAN NOT CONFIRM THE EMBEDDED EVENT REPORTED. INVESTIGATION CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED DEVICE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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 HISTORY LOT: PART: 310.250. LOT: 92P2822. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 24 MARCH 2021. 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.

    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, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON THAT (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE DRILL BIT BREAKS AT THE MOMENT OF DRILLING INTO THE BONE. THE PIECE OF DRILL BIT REMAINS INSIDE THE BONE. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø2.5 L110/85 2FLUTE F/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638528 DRILL BIT Ø2.5 L110/85 2FLUTE F/QC BITS, DRILL HTW SYNTHES GMBH 92P2822 07611819018631

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention