MAUDE Adverse Event Report: ARMIS BIOPHARMA, INC. VERIFIXX SMALL BONE IMPLANT; PIN, FIXATION, SMOOTH

Model Number HTASSY4-CR

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem Impaired Healing (2378)

Event Date 03/03/2021

Event Type  Injury  

Event Description

Quality check confirmed no problems during manufacturing process, distributed appropriately, and stored accurately.Dr.(b)(6) was aware that the patient was not complying with the instruction to stay off of her foot the week after the implant when she visited dr.(b)(6) office for post procedure office visit.Patient continued to walk extensively on her foot.Relevant dates below: date of surgery: (b)(6) 2021, first post op visit: (b)(6) 2021 (patient not compliant; bandage not on toe).Second post op visit (b)(6) 2021 (patient still not compliant; stitched removed; toe re-bandaged.Third post op visit (b)(6) 2021 (wound is open; dr.(b)(6) suspects implant separation and schedules patient for explant, implant removed and replaced with k-wire).As (b)(6) 2021 patient has made full recovery.Fda safety report id # (b)(4).

• Brand Name: VERIFIXX SMALL BONE IMPLANT
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARMIS BIOPHARMA, INC. ; 2950 east harmony road; ste 252; fort collins CO 80528
• MDR Report Key: 12225722
• MDR Text Key: 263511895
• Report Number: MW5102757
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HTASSY4-CR
• Device Lot Number: 24310062101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention