MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MINI BIO-PUSHLOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, MINI BIO-PUSHLOCK
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2025
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 04/15/2025, an arthrex subsidiary employee reported via email that the ar-8825b suture anchor tip bent weakly during the surgeon's insertion, and the anchor broke inside the patient.However, all fragments were retrieved.The procedure was completed using a replacement ar-8825b suture anchor.This was discovered during a tfcc repair procedure on (b)(6) 2025.Additional information has been requested.
Event or Problem Description
Additional information received on 5/13/2025: the anchor tip bent, but nothing broke in the patient.The case was delayed five minutes without additional anesthesia.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an ar-8825b, with batch number 15199828, revealed that the the anchor was damaged.Therefore, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse due to prying/leveraging the device during use.

• Brand Name: SUTURE ANCHOR, MINI BIO-PUSHLOCK
• 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: 21996010
• Report Number: 1220246-2025-01969
• Device Sequence Number: 15591853
• Product Code: MAI
• UDI-Device Identifier: 00888867046641
• UDI-Public: (01)00888867046641(11)240129(17)271231(10)15199828
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173240
• 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,Followup
• Report Date (Section B): 09/23/2025

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: SUTURE ANCHOR, MINI BIO-PUSHLOCK
• Device Catalogue Number: AR-8825B
• Device Lot Number: 15199828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 09/18/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/04/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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