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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
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
It was reported that during a bankart surgery the eyelet of the anchor broke when threading the suture.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-2922bc-1, biocomposite pushlock¿, batch 15252434, was received for investigation.Upon visual evaluation, it was noted that the anchor and eyelet were not returned for evaluation.The most likely cause for the reported failure can be attributed misuse due to misaligned insertion; or prying/leveraging the screw during insertion.Refer to investigation photos.The complaint allegation is confirmed.

• 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: 21909359
• Report Number: 1220246-2025-01740
• Device Sequence Number: 8794731
• 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): 07/29/2025

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: 07/14/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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