MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL; NON-DEGRADABLE FIXATN FASTENER

Model Number	SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 8th october 2025, it was reported by an arthrex employee via email that for an ar-3652sp, fibertak® rc suture anchor, (white/black), the fibertak rc anchor was placed into bone (medial row of rotator cuff repair) and set.Surgeon slid out the sliding suture from the anchor and found he had some resistance.He pulled quite hard and ended up pulling anchor out of bone.He found out as he looked at the anchor more closely that there was a little knot toward the end of the suture tape.He presumed that the resistance was due to the knot as it was trying to be passed through the sock caused the anchor to pull out of the bone.This was detected during use in a rotator cuff repair procedure on (b)(6) 2025.The procedure was completed successfully as another anchor was inserted.(b)(6) 2025 - the complaint initiator clarified that no implant did deploy successfully, it was as the surgeon tried sliding out the tape that the anchor pulled out because of the tiny knot at the end of the suture.
Additional Manufacturer Narrative
Complaint allegation is confirmed by the attached picture, which shows the white/blue suture had a knot.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.Per surgical technique lt1-000244-en - single-row rotator cuff repair - 2 - once the anchor has reached the laser insertion zone, remove the suture retention ring from the inserter handle and remove the inserter from bone.To set the anchor, grab all of the suture limbs and slowly pull back until resistance is met.3a - pass each repair suture separately by retrieving one repair suture through the lateral portal and passing it through the rotator cuff using a scorpion¿ suture passer.After the first repair suture is passed through the cuff, retrieve it through a working portal and repeat the steps to pass the second repair suture.After both repair sutures have been passed, retrieve both repair sutures and the loop end of the shuttle link through the lateral portal.Load the two repair sutures through the loop and convert the anchor.3b - optional ¿ after the anchor has been converted, load the shuttle link through the loops of the repair sutures, outside of the lateral cannula, to use as a counter-tension to provide more control while reducing the repair sutures to help prevent any suture tangles.The most likely cause of the reported failure can be attributed to user error of the device due to incorrect surgical technique during the knotless mechanism conversion process and/or excessive force applied during suture passage.

• Brand Name: SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 23299863
• Report Number: 1220246-2025-04603
• Device Sequence Number: 11961581
• Product Code: MBI
• UDI-Device Identifier: 00888867362901
• UDI-Public: (01)00888867362901(11)241126(17)291031(10)15353468
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
• Device Catalogue Number: AR-3652SP
• Device Lot Number: 15353468
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown