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

Model Number	CORKSCREW FT, BC, SUTURETAPE, 4.75MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/12/2026
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 12-jan-2026, a sales representative reported via email that an ar-1927bct-475 biocomposite corkscrew ft was used with the correct punch and tap due to hard bone quality.The surgeon inserted the corkscrew appropriately, and as the anchor was nearly flush with the bone, the inserter snapped completely, leaving a portion of the inserter lodged inside the anchor.The surgeon attempted to remove the retained inserter fragment but was unsuccessful and elected to leave both the anchor and the fragment implanted.This was discovered during an rcr procedure.Additional information was received on 16-jan-2026: the surgery occurred on (b)(6) 2026.The case was completed using a replacement ar-1927bct-475 biocomposite corkscrew ft.Although the surgery itself was not delayed, approximately 10 minutes were spent attempting to remove the fragment, but the fragment was left in place.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed by the attached picture, which shows the based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.Per dfu-0087-eo - e warnings - bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.G.Precautions - 3.Make sure to use the recommended drill bit or punch to create the bone socket.The most likely cause of the reported failure is consistent with mechanical overload of the inserter at the distal end during final advancement of the anchor, influenced by increased resistance, off-axis loading, misaligned insertion, or prying/leveraging forces, resulting in fracture and retention of a portion of the inserter within the anchor.

• Brand Name: CORKSCREW FT, BC, SUTURETAPE, 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 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24245184
• Report Number: 1220246-2026-00365
• Device Sequence Number: 8308988
• Product Code: MAI
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173788
• 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
• Report Date (Section B): 05/27/2026

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: CORKSCREW FT, BC, SUTURETAPE, 4.75MM
• Device Catalogue Number: AR-1927BCT-475
• Device Lot Number: 15493295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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