MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM KNOTLESS SUTURETAK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.0MM KNOTLESS SUTURETAK
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, a patient called in an inquiry about the material composition for ar-8934bck 3.0mm knotless suturetak.The patient reported that after undergoing a post tib tendon tear repair in her left foot on (b)(6) 2024, her bone is not healing.She was advised that she may be having a reaction and that the device could be removed.The patient wants to confirm if there is any metal in the device to determine if she is having a reaction.Additional information was provided on 08/22/2025 via phone where it was stated the patient has been experiencing alot of pain in the anchor site.Two mris have confirmed the bone around the anchor site itself has not healed.The patient has also had mild swelling in the tendon going up the back of her foot into the calf.An mri taken on (b)(6) 2025 presented metallic artifacts.The mri suggested a possible infection; however, bloodwork does not suggest an infection.It was mentioned that the surgeon suggested the patient may have (crps) complex regional pain syndrome.The patient has been going to physical therapy since the first week of (b)(6) 2025.The surgeon did reduce the navicular bone.The bone surrounding the anchor itself is what is not healing.The patient received a cortisone injection on (b)(6) 2025 and a second surgeon ordered a bone stimulator to attempt healing the bone.The patients pain level ranges from a 7-8.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to a patient-specific event.

• Brand Name: 3.0MM KNOTLESS SUTURETAK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23051770
• Report Number: 1220246-2025-03858
• Device Sequence Number: 13217620
• Product Code: MAI
• UDI-Device Identifier: 00888867380981
• UDI-Public: (01)00888867380981(11)240823(17)280731(10)15306758
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: 3.0MM KNOTLESS SUTURETAK
• Device Catalogue Number: AR-8934BCK
• Device Lot Number: 15306758
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown