MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM KNOTLESS SUTURETAK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.0MM KNOTLESS SUTURETAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/4/2024, it was reported by a sales representative via email that two ar-8934bck 3.0mm knotless suturetak anchors broke during insertion.This was discovered during a deltoid repair procedure on (b)(6) 2024.
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 received on 10/9/2024: all the broken fragments were removed.The case was completed using an ar-7220 fiberwire.The case was delayed fifteen minutes without additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an unpackaged ar-8934bck, with batch number 14946099, revealed a damaged anchor.Therefore, arthrex was able to deduce the cause of the complaint as misuse.The most likely cause for the reported failure can be attributed to misaligned insertion and/or prying/leveraging the device during insertion.

• Brand Name: 3.0MM KNOTLESS SUTURETAK
• 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: 20463686
• Report Number: 1220246-2024-08169
• Device Sequence Number: 7880801
• Product Code: MAI
• UDI-Device Identifier: 00888867380981
• UDI-Public: (01)00888867380981(11)220401(17)260331(10)14946099
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• 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
• Report Date (Section B): 08/21/2025

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: 03/31/2026
• Device Model Number: 3.0MM KNOTLESS SUTURETAK
• Device Catalogue Number: AR-8934BCK
• Device Lot Number: 14946099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 08/15/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 10/25/2024; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2022
• 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