MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH, BIO-COMP P - LCK, 2.4 X 11.3; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH, BIO-COMP P - LCK, 2.4 X 11.3
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bankart surgery the anchor broke at the end of the anchor when inserting the device into the glenoid.These particles could be completely removed by the suction on the shaver.The anchor itself held and was used to finish the procedure.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
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 allegation is confirmed based on the customer-provided photos.Visual evaluation of the customer-provided photos noted ar-2922bc-1 with a damaged tip.See attached photos.Based on the visual evaluation and 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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH, BIO-COMP P - LCK, 2.4 X 11.3
• 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: 21909330
• Report Number: 1220246-2025-01739
• Device Sequence Number: 17164937
• Product Code: MAI
• UDI-Device Identifier: 00888867197633
• UDI-Public: (01)00888867197633(11)240522(17)260430(10)15252434
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/11/2025

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: 04/30/2026
• Device Model Number: SUTR ANCH, BIO-COMP P - LCK, 2.4 X 11.3
• Device Catalogue Number: AR-2922BC-1
• Device Lot Number: 15252434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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