BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø1.5 W/STOP L19.5/6 2FLUTE

    MDR report key: 5857514 · Received August 9, 2016

    Report

    Report Number
    8030965-2016-14371
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 22, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFA
    PMA / PMN Number
    K043310
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING SUBSEQUENT FOLLOW-UP WITH THE REPORTER, ADDITIONAL INFORMATION WAS OBTAINED. IN REGARDS TO ¿MOJ¿ THE AFFILIATE IN (B)(4) SAYS THAT THIS IS THE BRAND NAME OF THE MATRIX PLATES AND SCREWS. MOJ STANDS FOR MATRIXORTHOGNATHIC IN (B)(4). MOJ IS NOT A DEVICE. THERE IS NO FURTHER INFORMATION AVAILABLE IN REGARDS TO UNDESIRED TREATMENT OUTCOME OR THE PATIENT CURRENT STATUS. HOWEVER, THE AFFILIATE CONFIRMED PATIENT HARM. NO INFORMATION AVAILABLE ON WHETHER VISUAL DAMAGE WAS PRESENT PRIOR TO USE. THE BROKEN PART REMAINED INSIDE OF THE PATIENT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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 FROM (B)(6) THAT DURING AN OSTEOTOMY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DRILL BIT DEVICE BROKE WHEN THE PHYSICIAN ATTEMPTED TO DRILL WITH AN UNSPECIFIED CONTRA-ANGLE ATTACHMENT DEVICE TO FIX THE OPERATED BONE USING "MOJ" AFTER OSTEOTOMY. IT WAS REPORTED THAT A FRAGMENT OF THE DRILL BIT DEVICE FELL INTO THE DRILLED BONE. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BROKEN FRAGMENT BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT REMOVING THE BROKEN FRAGMENT. IT WAS REPORTED THAT THERE WAS A DELAY IN THE PROCEDURE, BUT THE LENGTH OF DELAY WAS NOT REPORTED. THERE WAS NO ALLEGATION OF MALFUNCTION WITH THE ATTACHMENT DEVICE. IT WAS NOT REPORTED IF THERE WERE PATIENT INJURIES OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509837 DRILL BIT Ø1.5 W/STOP L19.5/6 2FLUTE BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL GFA DEPUY SYNTHES POWER TOOLS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention