MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH, DX SWVLK, BC, 1/PACK, 4.7 MM; NON-DEGRADABLE FIXATION FASTENER

Model Number	SUTR ANCH, DX SWVLK, BC, 1/PACK, 4.7 MM
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 8/26/2025, an employee from an arthrex subsidiary reported via email an issue involving the ar-8980bc-1 swivelock dx during a pl tendon fixation procedure on (b)(6) 2025.After the device was inserted, it dislodged from the bone socket while the eyelet suture was being removed.The tip of the screw was found to be deformed and damaged, rendering it unusable.Despite the complication, the tape and pl tendon were successfully sutured to the joint capsule, and the operation was completed without further incident as the patient¿s condition stabilized.No significant surgical delay was reported, and no additional anesthesia was administered.The bone socket had been drilled using a 2.4 guide pin and a 4.5 hollow drill, without the use of a tap.Bone quality was noted to be hard.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause of the reported failure is attributed to use-related mechanical overstress of the biocomposite interference screw during insertion, which can occur if the screw is subjected to high torque, misalignment, or engagement with a tunnel that is too tight or inconsistently prepared.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-8980bc-1 dx knotless swivelock, bc, 4.75 mm, batch 15346740, was received for evaluation.Visual inspection noted that the anchor was broken into multiple pieces.The eyelet showed no damage, and the molded inserter device was also free of defects.A functional test was performed by moving the inner and outer molded shaft, and no resistance was found.The sutures were not returned for evaluation.The most likely cause of the reported failure is attributed to use-related mechanical overstress of the biocomposite interference screw during insertion, which can occur if the screw is subjected to high torque, misalignment, or engagement with a tunnel that is too tight or inconsistently prepared.

• Brand Name: SUTR ANCH, DX SWVLK, BC, 1/PACK, 4.7 MM
• Common Device Name: NON-DEGRADABLE FIXATION 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: 23053989
• Report Number: 1220246-2025-03865
• Device Sequence Number: 18285814
• Product Code: MAI
• UDI-Device Identifier: 00888867319875
• UDI-Public: (01)00888867319875(11)241112(17)261031(10)15346740
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101823
• 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,Followup
• Report Date (Section B): 03/11/2026

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: SUTR ANCH, DX SWVLK, BC, 1/PACK, 4.7 MM
• Device Catalogue Number: AR-8980BC-1
• Device Lot Number: 15346740
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 03/10/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 01/30/2026; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown