MAUDE Adverse Event Report: ARTHREX, INC. 4.5 BIOCOMPOSITE FT WITH TIGERTAIL; BIO SOFT TISSUE FIXATN FASTNR

Model Number	4.5 BIOCOMPOSITE FT WITH TIGERTAIL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex employee via email that for an ar-1927bcft-45, 4.5 biocomposite ft with tigertail the implant broke.This was detected during a left shoulder rotator cuff repair procedure on (b)(6) 2025.The implant broke as surgeon was lightly grazing the anchor on bone surface to look for the hole.Procedure was successfully completed with no patient harm.The broken implant was removed from the operation site fully intact.
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 picture.Visual evaluation of the customer provided photo noted an ar-1927bcft-45 biocomposite corkscrew with a damaged anchor.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during insertion.

• Brand Name: 4.5 BIOCOMPOSITE FT WITH TIGERTAIL
• 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: 21346176
• Report Number: 1220246-2025-00350
• Device Sequence Number: 18411733
• Product Code: MAI
• UDI-Device Identifier: 00888867096844
• UDI-Public: 00888867096844
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (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): 09/22/2025

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: 4.5 BIOCOMPOSITE FT WITH TIGERTAIL
• Device Catalogue Number: AR-1927BCFT-45
• Device Lot Number: 1539226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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