MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK P-LCK,2.9X 12.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/04/2025, a sales representative reported via email an issue involving an ar-2923ps peek pushlock sl anchor.The anchor was loaded with two tails of #2 fiberwire, which had been passed around the labrum.Following the creation of a pilot hole using the drill and guide from an ar-1926ds, the instruments were removed, and the anchor was inserted through a gemini cannula in the anteroinferior portal.As the pushlock was advanced into the joint and tension applied to approximate the labral tissue to the eyelet, the eyelet broke off the tip of the pushlock, rendering it unusable.The case was delayed by approximately 10 minutes to troubleshoot the issue with the anchor and subsequent devices before switching to fibertak anchors to complete the procedure.This was discovered during a procedure on (b)(6) 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: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 06/25/2025: this occurred during a bankart repair procedure on (b)(6) 2025.All fragments were retrieved.The case was completed utilizing an ar-3636 instead of the pushlock.The case was delayed 5-7 minutes, which required additional anesthesia in that timeframe.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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.The most likely cause for the reported failure can be attributed to normal wear and tear due to repeated use of the device in the field.Manufacturing date 2021.
Additional Manufacturer Narrative
Corrected additional information: h6 - investigation findings complaint allegation is confirmed by the attached picture, which shows the implant (eyelet) was broken off.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.The most likely cause of the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
• 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: 22337854
• Report Number: 1220246-2025-02678
• Device Sequence Number: 9160519
• Product Code: MAI
• UDI-Device Identifier: 00888867028036
• UDI-Public: (01)00888867028036(11)221213(17)271130(10)15033712
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/15/2025

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: SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923PS
• Device Lot Number: 15033712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 09/29/2025; Not provided
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/21/2025; 10/06/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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