MAUDE Adverse Event Report: ARTHREX, INC. BC SWIVELOCK, 3.9X17.9MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BC SWIVELOCK, 3.9X17.9MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/8/2025, an arthrex subsidiary employee reported via email that an ar-2326bcc biocomposite swivelock eyelet rotated simultaneously with the anchor during insertion.As a result, the sutures became entangled in the screw, rendering it unusable.The case was successfully completed using another ar-2326bcc biocomposite swivelock.This issue was initially discovered during a procedure on (b)(6) 2025.Additional information requested on 5/29/2025.
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.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation cannot be confirmed.The customer's attached picture does not provide evidence of the device's malfunction.
Event or Problem Description
Additional information: this was discovered during an ac internalbrace procedure.Nothing broke in the patient, and the case was not delayed.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.One unpackaged ar-2326bcc swivelock®, batch 15352660, was received for investigation.Visual inspection noted that the anchor and eyelet were still intact.The sutures were not returned for evaluation.The anchor and eyelet exhibited slight surface damage.The method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.The most likely cause can be attributed misuse due to improper bone preparation; misaligned insertion; or prying/leveraging the device during insertion.

• Brand Name: BC SWIVELOCK, 3.9X17.9MM
• 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: 22131863
• Report Number: 1220246-2025-02345
• Device Sequence Number: 20934739
• Product Code: MAI
• UDI-Device Identifier: 00888867311282
• UDI-Public: (01)00888867311282(11)241125(17)281031(10)15352660
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230435
• 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): 12/19/2025

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: BC SWIVELOCK, 3.9X17.9MM
• Device Catalogue Number: AR-2326BCC
• Device Lot Number: 15352660
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 10/08/2025; 12/18/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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