BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST DRILL

    MDR report key: 6873438 · Received September 18, 2017

    Report

    Report Number
    0001032347-2017-00730
    Event Type
    Injury
    Date Received
    September 18, 2017
    Date of Event
    August 7, 2017
    Report Date
    February 23, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    PK062842
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE DRILL WAS VISUALLY EVALUATED AND FOUND TO BE IN GOOD COSMETIC CONDITION; NO DISCOLORATION WAS OBSERVED. THE DRILL HAS A TRANSVERSE FRACTURE THROUGH THE FLUTES NEAR THE NECK OF THE DRILL THAT IS TYPICAL FROM EXCESSIVE FORCE. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO REPEATED USE OF A SINGLE USE ITEM. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT STATES IN THE WARNINGS AND PRECAUTIONS SECTION: ¿EXCESSIVE FORCE MAY CAUSE UNUSUAL STRESS CONDITIONS AND RESULT IN BREAKAGE OR FRACTURE OF THE DEVICE.¿ THE DRILL IS ALSO INDICATED AS A SINGLE USE ITEM, AND IT WAS REPORTED THAT ¿THIS DRILL WAS USED A LOT AS LOANER ITEM.¿ 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.

    Additional Manufacturer Narrative · 1

    LOT #: BASED ON A COMPARISON OF INVENTORY TRANSACTIONS AND THE SALES HISTORY FOR THIS ACCOUNT, THERE ARE FIVE (5) POSSIBLE LOTS: 140980 (B)(4). 890320 (B)(4). 131470 (B)(4). 675000 (B)(4). 853990 (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THE LOTS WERE RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE IS LABELED FOR SINGLE USE, HOWEVER THE DISTRIBUTOR REPORTED IT HAS BEEN USED MULTIPLE TIMES; THE EXACT NUMBER OF USES IS UNKNOWN. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A DRILL FRACTURED IN THE PATIENT'S MANDIBLE DURING A PROCEDURE. THE PATIENT DID NOT RETAIN A FOREIGN BODY, THE BROKEN DRILL WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF LESS THAN THIRTY MINUTES. THE SURGEON STATED THE PATIENT¿S BONE WAS SOFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654336 TWIST DRILL TWIST DRILL 1.1X105MM 18MM STOP HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention