BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP

    MDR report key: 11051099 · Received December 21, 2020

    Report

    Report Number
    0001032347-2020-00612
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 20, 2020
    Report Date
    August 11, 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 (354507) ETCHED ON THE PRODUCT IS THE VENDOR'S LOT NUMBER. FOLLOWING A REVIEW OF PRODUCTION RECORDS AND THE CUSTOMER'S PURCHASE HISTORY, THE FOLLOWING FOUR (4) LOT NUMBERS ARE POTENTIAL ZIMMER BIOMET LOT NUMBERS: 054370, 201500, 423410, OR 855320. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: ITEM#: 24-2050 LOT#: 201500. MANUFACTURE DATE: 14 JUL 2020. UDI: (B)(4). ITEM#: 24-2050 LOT#: 423410. MANUFACTURE DATE: 22 MAR 2021. UDI: (B)(4). ITEM#: 24-2050 LOT#: 855320. MANUFACTURE DATE: 10 MAY 2021. UDI: (B)(4). VISUAL EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE PRODUCTS' IDENTITY. THE DRILL WAS CONFIRMED TO BE FRACTURED, NEAR THE START OF THE FLUTED SECTION OF THE DRILL. BOTH DRILLS WERE CONFIRMED TO BE FRACTURED, NEAR THE START OF THE FLUTED SECTION OF THE DRILL. ONE OF THE TWO FRACTURED FLUTED SECTIONS ALSO HAD A CLEAR BEND IN IT, BUT IT COULD NOT BE CONFIRMED IF THE BEND WAS ON THE DRILL FROM LOT 354507 OR 321017. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2020-00613. LOT NUMBER: 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 TWO (2) LOT NUMBERS ARE POTENTIAL LOT NUMBERS: 201500, 054370. MEDICAL PRODUCTS: TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP, PART# 24-2050, LOT# UNK. TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP, PART# 24-2050, LOT# UNK. THE USER FACILITY IS FOREIGN, THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO (2) DRILL BITS FRACTURED DURING A MANDIBULAR PROCEDURE. THE SURGEON REPORTED THE INSTRUMENTS SHOOK DURING ROTATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510867 TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A 054370 00841036059279

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR