BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    MDR report key: 5495755 · Received March 11, 2016

    Report

    Report Number
    1719045-2016-10212
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    February 26, 2016
    Report Date
    February 26, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FSM
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(6). ADDITIONAL PRODUCT CODE ¿ HTW. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW - RELEASE TO WAREHOUSE DATE: 09APR2015. SUPPLIER: (B)(4), PACKAGED BY: SYNTHES: (B)(4). NO NCRS 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. 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

    ADDITIONAL INFORMATION - THE PATIENT'S STATUS WAS REPORTED AS "GOOD." THERE WAS A TWO (2) MINUTE SURGICAL DELAY NOTED, HOWEVER THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DRILLING THE PROXIMAL DYNAMIC LOCKING SCREW HOLE FOR A LATERAL ENTRY FEMORAL NAIL, THE DRILL BIT MADE A NOISE SOUNDING LIKE IT WAS HITTING A NAIL. UPON WITHDRAWAL OF THE DRILL BIT, SOME SHARDS OF METAL WERE EVIDENT ON A FLUOROSCOPY. INSPECTION OF THE DRILL BIT REVEALED A SMALL PIECE OF THE TIP HAD BROKEN OFF AND A PORTION OF THE FLUTE HAD SHEARED OFF. THE SURGEON BRIEFLY ATTEMPTED TO RETRIEVE THE METAL AND THEN ABANDONED THE ATTEMPT. THE METAL REMAINED IN THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151916 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION TRAY,SURGICAL INSTRUMENT FSM SYNTHES MONUMENT 7766733

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention