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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 22nd august 2025, it was reported by an arthrex employee via email that for an ar-2923bc-1, suture anchor, biocomposite pushlock®, sl 2.9 mm x 12.5 mm, the pushlock anchor was damaged on insertion into glenoid and would not advance.This was detected during use in a labral repair procedure on (b)(6) 2025.The procedure was completed successfully as they used another anchor.Patient bone quality was as expected for age.The correct guide and drill were used for preparation of the bone.
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.Complaint allegation is confirmed by the attached picture, which shows the anchor 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,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: 23051850
• Report Number: 1220246-2025-03859
• Device Sequence Number: 13217727
• Product Code: MAI
• UDI-Device Identifier: 00888867269170
• UDI-Public: (01)00888867269170(11)250605(17)270531(10)15446911
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/08/2025

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: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923BC-1
• Device Lot Number: 15446911
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown