BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 LACTOSORB SYSTEM 2.0 X 5 MM LACTOSORB SCREW

    MDR report key: 7519401 · Received May 16, 2018

    Report

    Report Number
    0001032347-2018-00277
    Event Type
    Injury
    Date Received
    May 16, 2018
    Date of Event
    November 10, 2017
    Report Date
    October 31, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK002083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE SCREW (PART# 915-2300, LOT# 933870) SHOWED THAT THERE WAS A FRACTURE, LOCATED NEAR THE THREADS IN THE BODY OF THE SCREW. THE COMPLAINT STATES THAT THE FRACTURE OCCURRED DURING THE PROCESS OF "NAILING." IT IS NOT KNOWN EXACTLY WHAT IS MEANT BY "NAILING" BUT PROPER TECHNIQUE SHOULD BE FOLLOWED BY TWISTING EACH SCREW INTO A PRE-TAPPED HOLE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT STATES IN THE SECTION TITLE WARNINGS: IMPROPER SELECTION, PLACEMENT, POSITIONING, OR FIXATION OF THE IMPLANT CAN CAUSE A SUBSEQUENT UNDESIRABLE RESULT. DEVICES SHOULD NOT BE LOCATED DIRECTLY UNDER A SUTURE SITE. THE SURGEON IS TO BE FAMILIAR WITH THE DEVICES, THE METHOD OF APPLICATION AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY. ALSO STATED 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. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE BEING APPLIED TO THE SCREW DURING INSERTION. 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT THE RESULTS OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

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

    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 SCREWS FRACTURED NEAR OR AT THE HEAD OF THE SCREW. THE SURGEON REPLACED THE BROKEN SCREWS. THERE WAS A FIVE MINUTE DELAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREW FRACTURED "IN THE PROCESS OF NAILING." ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361204 2.0 LACTOSORB SYSTEM 2.0 X 5 MM LACTOSORB SCREW BONE SCREW JEY BIOMET MICROFIXATION N/A 933870

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention