BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIM-IT FIXATION SCREW, 2.7 MM X 30 MM

    MDR report key: 1972875 · Received January 28, 2011

    Report

    Report Number
    1220246-2011-00012
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K041189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. BOTH SIDES OF THE SCREW WERE CUT. THE PATIENT'S CONDITION AS REPORTED COULD BE RELATED TO AN ADVERSE PATIENT REACTION TO ANY OF THE MATERIALS IMPLANTED AND CANNOT BE DETERMINED FROM EVALUATION OF THE PARTIAL RETURNED DEVICE. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. ABSORPTION OF BIODEGRADABLE IMPLANTS BEGINS AT IMPLANTATION AS A RESULT OF NORMAL HYDROLYSIS OF THE IMPLANT. THE RATE AT WHICH THE IMPLANT DEGRADES AND IS REABSORBED CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO IMPLANTATION SITE VASCULARITY, STRESS ON THE IMPLANTS, SURGICAL TECHNIQUES EMPLOYED DURING IMPLANTATION, PATIENT FACTORS (SUCH AS AGE, IMMUNE SYSTEM STATUS, BONE QUALITY, BODY CHEMISTRY AND SENSITIVITY TO IMPLANT MATERIALS), AND PATIENT POST-OP COMPLIANCE TO REHABILITATION PROTOCOLS. THERE IS NO MINIMUM OR MAXIMUM ESTABLISHED RESORPTION RATES FOR BIOABSORBABLE IMPLANTS. BIOABSORBABLE IMPLANTS ARE DESIGNED WITH MATERIAL QUALITIES REQUIRED TO MAINTAIN NECESSARY PROPERTIES THROUGHOUT THE HEALING PROCESS UNDER NORMAL PATIENT CONDITIONS. PRODUCT DIRECTIONS FOR USE WARNS OF POSSIBLE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT NUMBER COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    PATIENT HAD 19-MONTH POST-OP REACTION; PAIN AND SWELLING. DOS (B)(6) 2009. BI-LATERAL BUNIONECTOMY ON BOTH FEET. PER SURGEON, 'FOREIGN BODY REACTION'; PIN HAD NOT ABSORBED. LEFT FOOT X-RAY SHOWED THE PIN INTACT, IT HAD NOT MIGRATED. SECOND SURGERY, (B)(6) 2010, IT WAS REMOVED. NOTHING WAS PUT IN ITS PLACE. PER SURGEON, THE BONE CUT HAD HEALED. RIGHT FOOT PIN NOT BEING RETURNED. PT WAS GIVEN PERCOCET FOR PAIN AND MOBIC FOR INFLAMMATION. LEVOXYL (THYROID), ESTRADIOL (HORMONES). PATIENT: NON SMOKER, NO ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIM-IT FIXATION SCREW, 2.7 MM X 30 MM SCREW, FIXATION, BONE HWC ARTHREX, INC. 208504

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other AR-4161B, LOT 208504