BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP

    MDR report key: 10999094 · Received December 13, 2020

    Report

    Report Number
    0001032347-2020-00600
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Date of Event
    November 12, 2020
    Report Date
    August 10, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036059279
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: THE LOT NUMBER (321017) ETCHED ON THE PRODUCT RETURNED FOR INVESTIGATION IS THE VENDOR'S LOT NUMBER. FOLLOWING A REVIEW OF PRODUCTION RECORDS AND THE CUSTOMER'S PURCHASE HISTORY, THE FOLLOWING SEVEN (7) LOT NUMBERS ARE POTENTIAL ZIMMER BIOMET LOT NUMBERS: 229460, 418100, 418120, 895130, 895210, 895220, OR 895240. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: ITEM#: 24-2050 LOT#: 418100. MANUFACTURE DATE: 24 JUN 2019. UDI: (B)(4). ITEM#: 24-2050 LOT#: 418120. MANUFACTURE DATE: 24 JUN 2019. UDI: (B)(4). ITEM#: 24-2050 LOT#: 895130. MANUFACTURE DATE: 17 JUL 2019. UDI: (B)(4). ITEM#: 24-2050 LOT#: 895210. MANUFACTURE DATE: 17 JUL. UDI: (B)(4). ITEM#: 24-2050 LOT#: 895220. MANUFACTURE DATE: 17 JUL 2019. UDI: (B)(4). ITEM#: 24-2050 LOT#: 895240. MANUFACTURE DATE: 17 JUL 2019. UDI: (B)(4). VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE PART TO BE FRACTURED. BOTH PIECES WERE RETURNED. THIS CONFIRMS THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DRILL TIP BROKE WHEN THE SURGEON TRIED TO DRILL A PILOT HOLE DURING A MANDIBULAR RECONSTRUCTION SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRILL BIT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). 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. THE LOT NUMBER PROVIDED BY THE CUSTOMER IS THE VENDOR LOT NUMBER. BASED ON A REVIEW OF THE VENDOR LOTS AND THE CUSTOMER¿S PURCHASE HISTORY, THE FOLLOWING SEVEN (7) LOT NUMBERS ARE POTENTIAL LOT NUMBERS: 895130, 895240, 895220, 895210, 418100, 418120, 229460. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL TIP BROKE WHEN THE SURGEON TRIED TO DRILL A PILOT HOLE DURING A MANDIBULAR RECONSTRUCTION SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRILL BIT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464112 TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A 229460 00841036059279

    Patients

    Seq Age Sex Outcome Treatment
    1