MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 5.5MM BC SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DBL LOADED 5.5MM BC SWVLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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 10/16/2025, a distributor reported via email that an ar 2323bct-2 biocomposite swivelock suture anchor broke during use.While inserting the anchor into the pilot hole, using the correct punch, the surgeon observed that the eyelet of the anchor broke, rendering the device defective.No fragments remained in the patient.This incident occurred during a rotator cuff repair procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 10/22/2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 the complaint allegation is confirmed based on photographic evidence of a damaged ar-2323bct-2, batch 15454850.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, the event description, and any additional field input ¿ arthrex has determined the most likely cause of the reported failure.The most likely cause is attributed to use-related factors, including misaligned insertion, improper bone preparation, and/or prying or levering of the device during insertion, which likely resulted in excessive loading and subsequent device fracture.
Event or Problem Description
Additional information: an ar 2323bct-2 was used to complete the case.The surgery experienced a minor delay of approximately 5 minutes.However, no additional anesthesia was administered to the patient due to this delay.No adverse patient effects have been reported during or following the procedure in relation to this issue.

• Brand Name: DBL LOADED 5.5MM BC SWVLK
• 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: 23390110
• Report Number: 1220246-2025-04825
• Device Sequence Number: 15920626
• Product Code: MAI
• UDI-Device Identifier: 00888867251069
• UDI-Public: (01)00888867251069(11)250623(17)270531(10)15454850
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: DBL LOADED 5.5MM BC SWVLK
• Device Catalogue Number: AR-2323BCT-2
• Device Lot Number: 15454850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown