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

Model Number	SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
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 06/09/2025, an arthrex subsidiary employee reported via email that an ar-2923bc biocomposite pushlock anchor had the tip of the eyelet broken.The procedure was completed using another ar-2923bc biocomposite pushlock anchor.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 06/23/2025: this issue occurred upon implant insertion on the patient during an arthroscopic bankart repair on (b)(6) 2025.All fragments were retrieved from the patient.There was no case delay, and no added anesthesia was administered.No adverse effects were reported on or after the surgery.
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 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,BIO-COMP 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: 22396698
• Report Number: 1220246-2025-02728
• Device Sequence Number: 11987188
• Product Code: MAI
• UDI-Device Identifier: 00888867099203
• UDI-Public: (01)00888867099203(11)241021(17)260930(10)15334862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101679
• 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
• Report Date (Section B): 10/06/2025

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 Expiration Date: 09/30/2026
• Device Model Number: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923BC
• Device Lot Number: 15334862
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown