BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 6057120 · Received October 26, 2016

    Report

    Report Number
    1719045-2016-10782
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: GFF, GFA, HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PHONE EXTENSION: (B)(6). PART 310.25, LOT U231963: RELEASE TO WAREHOUSE DATE: SEPTEMBER 22, 2015. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION; REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 PATIENT UNDERWENT AN ANKLE FUSION OPEN REDUCTION INTERNAL FIXATION (ORIF) ON (B)(6) 2016. WHILE THE SURGEON WAS DRILLING THROUGH A 3.5MM LOCKING COMPRESSION PLATE (LCP) RECONSTRUCTION PLATE TO INSERT SCREWS THE 2.5MM DRILL BIT BROKE. THE BROKEN FRAGMENT WAS NOT RETRIEVED TO AVOID BONE DESTRUCTION. A ROUTINE X-RAY WAS TAKEN AND CONFIRMED THE FRAGMENT FINDING. AN ALTERNATIVE TOOL WAS AVAILABLE FOR THE SURGEON TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION AFTER THE SURGERY. NO SURGICAL DELAY WAS REPORTED. CONCOMITANT DEVICES REPORTED: 3.5MM LOCKING COMPRESSION PLATE (LCP) RECONSTRUCTION PLATE (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707900 2.5MM DRILL BIT/QC/GOLD/110MM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES MONUMENT U231963

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention UNKNOWN 3.5MM LCP RECONSTRUCTION PLATE