BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW

    MDR report key: 7352244 · Received March 20, 2018

    Report

    Report Number
    0001032347-2018-00133
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    November 29, 2017
    Report Date
    June 29, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    NHB
    PMA / PMN Number
    PK012409
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MICROFIXATION 1.5 X 4 MM LACTOSORB SCREW CATALOG #: 915-2315 LOT #: 756970, BIOMET MICROFIXATION 2.0 X 5 MM LACTOSORB SCREW CATALOG #: 915-2300 LOT #: 801350, UNKNOWN 5MM DRILL CATALOG #: NI LOT #: NI, UNKNOWN 6MM TAP CATALOG #: NI LOT #: NI. THERAPY DATE: (B)(6) 2017. REPORT SOURCE: FOREIGN COUNTRY - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, THEY WERE DISCARDED BY THE FACILITY. 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 REPORTS: 0001032347-2018-00131 AND 0001032347-2018-00132.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. PRODUCT IDENTITIES COULD NOT BE CONFIRMED DUE TO THE PRODUCTS NOT BEING RETURNED. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE PRODUCTS BEING SCRAPPED AND NOT BEING AVAILABLE FOR RETURN. IN ADDITION, THERE WERE NO PHOTOGRAPHS, X-RAYS, SCANS OR PHYSICIAN REPORTS TO SUBSTANTIATE THE COMPLAINT. THEREFORE, THE COMPLAINT CANNOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE CANNOT BE DETERMINED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE (IFU) ALSO HAS THE FOLLOWING INFORMATION IN THE SECTION TITLED PRECAUTIONS: INSTRUMENTS ARE AVAILABLE TO AID IN THE ACCURATE IMPLANTATION OF LACTOSORB FIXATION DEVICES. INTRAOPERATIVE FRACTURE OF INSTRUMENTS HAS BEEN REPORTED. SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS THAT HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS ARE ONLY TO BE USED FOR THEIR INTENDED PURPOSE. ALL INSTRUMENTS ARE TO BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT. 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. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00131-1 AND 0001032347-2018-00132-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FIXED FIRST AND SECOND SCREWS FRACTURED OR CAME OUT OF THE PATIENT'S TEMPORAL BONE WHEN THE SURGEON ATTEMPTED TO INSERT THE THIRD SCREW TO FIX THE SQUARE PLATE. AFTER THAT, THE SURGEON DRILLED AND TAPPED USING THE 5MM DRILL AND THE 6MM TAP, WHEN HE ATTEMPTED TO INSERT THE SCREW FIXATION COULD NOT BE ACHIEVED THE SCREW IDLY ROTATED. THE SURGERY WAS COMPLETE USING SURGICAL SUTURES TO FIX THE AUTOGENOUS BONE AND BONE FLAP WITHOUT ANY DELAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196999 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW BONE SCREW; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB BIOMET MICROFIXATION N/A 828000

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention