BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM X 30MM CANNULATED HEADLESS SCREW

    MDR report key: 8260585 · Received January 18, 2019

    Report

    Report Number
    2027754-2019-00002
    Event Type
    Injury
    Date Received
    January 18, 2019
    Date of Event
    December 20, 2018
    Report Date
    December 27, 2018
    Manufacturer
    OSTEOMED
    Product Code
    HWC
    UDI-DI
    00845694027083
    PMA / PMN Number
    K090522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE Ø2.0MM X 30MM CANNULATED HEADLESS SCREW, P/N 317-2030, WAS NOT RETURNED FOR EVALUATION. THE PATIENTS' FINGER BECAME INFECTED TWO WEEKS POST-OP. THIS SCREW WAS USED DURING THE SURGERY, BUT HAS NOT BEEN DETERMINED TO BE THE CAUSE OF THE INFECTION. POSSIBILITIES THAT COULD HAVE CAUSED THE INFECTION ARE NUMEROUS. ONE POSSIBILITY IS THAT THIS, OR ANOTHER INSTRUMENT OR IMPLANT, WAS NOT STERILIZED PROPERLY. ONE POSSIBILITY IS THAT THIS, OR ANOTHER INSTRUMENT OR IMPLANT, WAS NOT STERILIZED PROPERLY. IT MAY BE A POSSIBILITY THAT THE PATIENT HAD A PRE-EXISTING INFECTION PRIOR TO THE SURGERY. IT MAY BE A POSSIBILITY THAT THE INFECTION WAS INTRODUCED AFTER THE SURGERY. IT MAY BE A POSSIBILITY THAT THE SURGERY SITE WAS CONTAMINATED DURING SURGERY. IT WAS REPORTED THAT THE INSTRUMENTS AND IMPLANTS WERE STERILIZED PRE-OP, AND THAT THE PATIENT DID NOT HAVE AN INFECTION PRE-OP. THE ROOT CAUSE FOR THE INFECTION DISCOVERED TWO WEEKS POST-OP COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD FOR THAT LOT COULD NOT BE PERFORMED. A TWO-YEAR REVIEW DID NOT IDENTIFY ANY CAPAS RELATED TO THIS SCREW FAMILY, P/N 317-20XX. A TWO-YEAR REVIEW OF THE NCR DATABASE SHOWED ONLY ONE (1). THE NCR WAS UNRELATED TO THIS ISSUE. THIS SCREW IS A PART OF THE EXTREMIFIX 2.0/2.4 CANNULATED SCREW SYSTEM. ALTHOUGH THERE IS NO PROOF THAT THE SCREW CAUSED ANY INFECTION, THIS WOULD BE THE WORST RISK TO REVIEW. THE RISK OF AN INFECTION DUE TO AN UNSTERILE SCREW IS COVERED IN THE FMEA. THE POTENTIAL CAUSE HAS A SEVERITY RATING OF 4. PER THE RISK MANAGEMENT PROCEDURE, A RATING OF 4 INDICATES A "CRITICAL" SEVERITY LEVEL (RESULTS IN PERMANENT IMPAIRMENT REQUIRING PROFESSIONAL MEDICAL INTERVENTION). THE FINAL PREDICTED RISK LEVEL IS "HIGH". THE EXTREMIFIX 2.0/2.4MM INSTRUCTION FOR USE INFORMS THE USER THAT SCREWS ARE SINGLE USE IMPLANTS THAT CANNOT BE REUSED AND/OR REPROCESSED. DOING SO MIGHT LEAD TO POTENTIAL RISKS OF CROSS INFECTION/CONTAMINATION ASSOCIATED WITH USING INADEQUATELY CLEANED AND STERILIZED DEVICES. THE IFU WARNS THAT USE OF THIS IMPLANT IS CONTRAINDICATED IN CASES OF ACTIVE OR SUSPECTED INFECTION OR IN PATIENTS WHO ARE IMMUNOCOMPROMISED; IN PATIENTS PREVIOUSLY SENSITIZED TO TITANIUM; OR IN PATIENTS WITH CERTAIN METABOLIC DISEASES. FINALLY, THE IFU STATES THIS IMPLANT IS SUPPLIED NON-STERILE AND MUST BE STERILIZED PRIOR TO USE. THIS ISSUE WILL BE MONITORED THROUGH ROUTINE TRENDING.

    Description of Event or Problem · 1

    ON (B)(4) 2018, OSTEOMED WAS NOTIFIED OF AN ISSUE WITH OUR 2.0MM X 30MM CANNULATED HEADLESS SCREW. THE PHYSICIAN PERFORMED A CASE ON (B)(6) 2018 WHERE HE PUT A OSTEOMED SCREW IN A DIP FUSION LEFT INDEX. TWO (2) WEEKS LATER THE PATIENT HAS AN INFECTION ON THE OPERATIVE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54323 2.0MM X 30MM CANNULATED HEADLESS SCREW 2.0MM X 30MM CANNULATED HEADLESS SCREW HWC OSTEOMED UNKNOWN 00845694027083

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention