MAUDE Adverse Event Report: ARTHREX, INC. BC, CORKSCREW FT, TRI-PLAY, 4.75MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BC, CORKSCREW FT, TRI-PLAY, 4.75MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
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 (b)(6) 2025, it was reported by an arthrex subsidiary employee via email that an ar-1927bcf-475 biocomposite corkscrew ft anchor broke when it was implanted and turned clockwise.All the broken fragments were removed, and the case was completed using another r-1927bcf-475 biocomposite corkscrew ft.This was discovered during an rcr procedure on (b)(6) 2025.The case was not delayed, and additional anesthesia was not needed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Based on the image of the ar-1927bcf-475 provided from the field, it was noted that the screw was damaged/warped.Consequently, arthrex was able to conclude a most likely cause.The most likely cause can be attributed to misaligned insertion, or prying/leveraging the screw during insertion.

• Brand Name: BC, CORKSCREW FT, TRI-PLAY, 4.75MM
• 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: 21395241
• Report Number: 1220246-2025-00510
• Device Sequence Number: 20905950
• Product Code: MAI
• UDI-Device Identifier: 00888867238541
• UDI-Public: (01)00888867238541(11)240417(17)280331(10)15235895
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173788
• 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): 09/05/2025

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: BC, CORKSCREW FT, TRI-PLAY, 4.75MM
• Device Catalogue Number: AR-1927BCF-475
• Device Lot Number: 15235895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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