BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM CANNULATED DRILL BIT/QC 150MM

    MDR report key: 4965457 · Received August 4, 2015

    Report

    Report Number
    1719045-2015-10493
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED: AVALIGN TECHNOLOGIES - NGINSTRUMENTS MANUFACTURED THE 2.0MM CANNULATED DRILL BIT / QC, 150MM, PART NUMBER 310.221, LOT 7821467. THE CERTIFICATE OF CONFORMANCE INDICATED THE LOT WAS PROCESSED AND CONFORMED TO SPECIFICATION REQUIREMENTS. THE LOT WAS INSPECTED AND CONFORMED TO THE INCOMING FINAL INSPECTION SHEET. THERE WERE NO COMPLAINT-RELATED ANOMALIES, MATERIAL REVIEW REPORTS, OR NON-CONFORMANCE REPORTS ASSOCIATED WITH THIS LOT. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 19JANUARY2015. 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

    IT WAS REPORTED THAT THE DISTAL TIP OF A DRILL BIT BROKE OFF WHILE DRILLING OVER A WIRE DURING A METATARSOPHALANGEAL (MTP) FUSION INTRA-OPERATIVELY ON (B)(6) 2015. AN APPROXIMATE FIFTEEN (15) MINUTE SURGICAL DELAY WAS REPORTED, AND THREE TO FOUR (3-4) ADDITIONAL X-RAYS WERE TAKEN. SOME OF THE FRAGMENTS WERE RETRIEVED, AND SOME WERE LEFT BEHIND. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506870 2.0MM CANNULATED DRILL BIT/QC 150MM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES MONUMENT 7821467

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention