MAUDE Adverse Event Report: ARTHREX, INC. TITANIUM SWIVELOCK, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	TITANIUM SWIVELOCK, 4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 (b)(6) 2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-2324slm suture anchors suture was cut and the anchor was released.This occurred during a rotator cuff repair, that was completed using another product.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based of the customer's attached picture that display anar-2324slm suture anchor, swivelock® sp, 4.75 mm x 24.5 mm self punching, vented with the blue suture broken and the device disassembled.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 that the allegation on the ar-2324slm was confirmed, and the reported failure is most likely related to a user error following the device's correct surgical technique.

• Brand Name: TITANIUM SWIVELOCK, 4.75X19.1MM
• 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: 20683915
• Report Number: 1220246-2024-08525
• Device Sequence Number: 15592821
• Product Code: MAI
• UDI-Device Identifier: 00888867026940
• UDI-Public: (01)00888867026940(11)231214(17)281130(10)15180805
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: TITANIUM SWIVELOCK, 4.75X19.1MM
• Device Catalogue Number: AR-2324SLM
• Device Lot Number: 15180805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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