BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAUMAONE SYSTEM DRILL, 1.6X50MM 22MM STOP

    MDR report key: 8004526 · Received October 25, 2018

    Report

    Report Number
    0001032347-2018-00693
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    September 25, 2018
    Report Date
    February 13, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    K062842
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT IDENTITIES WERE CONFIRMED. THE TWO (2) TRAUMAONE SYSTEM DRILLS, 1.6X50MM 22MM STOP (PART# 46-1006, SER# 252523, 233344) WERE VISUALLY EVALUATED. THE DRILL BITS WERE BOTH FRACTURED AT THE POINT WHERE THE FLUTED SECTION OF THE DRILL BEGINS. THE FRACTURED FLUTED SECTION OF THE SERIAL # 233344 DRILL WAS ALSO SIGNIFICANTLY BENT. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE, BEYOND WHAT THE DRILL IS DESIGNED TO ENCOUNTER, APPLIED DURING THE DRILLING PROCESS. CONTRIBUTING FACTORS MAY HAVE BEEN THE DRILL BEING USED OFF AXIS OR HITTING A HARD SPOT IN THE BONE WHICH SLOWS DOWN OR STOPS ROTATION OF THE TIP OF THE DRILL. THE INSTRUCTIONS FOR USE (IFU) FOR THESE PRODUCTS STATES IN THE SECTION TITLED 'WARNINGS AND PRECAUTIONS': INTRAOPERATIVE FRACTURE OR BREAKING OF TWIST DRILLS HAS BEEN REPORTED. EXCESSIVE FORCE MAY CAUSE UNUSUAL STRESS CONDITIONS AND RESULT IN BREAKAGE OR FRACTURE OF THE DEVICE. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00027-1.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED, IT WAS REPORTED THAT THE PATIENT HAD A MANDIBULAR BRANCH FRACTURE ON BOTH SIDES.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN COUNTRY - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL BIT FRACTURED WHILE DRILLING THE PILOT HOLE DURING L-MANDIBLE PROCEDURE. AFTER DRILLING THE NURSE FOUND THE DRILL TIP WAS BROKEN, AN X-RAY WAS TAKEN AND CONFIRMED BY THE DENTIST THAT THE FRACTURED PART WAS RETAINED IN THE MANDIBLE. THE FRACTURED DRILL WAS REMOVED FROM THE PATIENT BY WHITTLING THE PERIPHERY BONE. THE INCIDENT CAUSED A DELAY OVER THIRTY (30) MINUTES, HOWEVER THE EXACT DURATION OF THE DELAY IS UNKNOWN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846100 TRAUMAONE SYSTEM DRILL, 1.6X50MM 22MM STOP DRILL HBE BIOMET MICROFIXATION N/A 945980

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention