MAUDE Adverse Event Report: ARTHREX, INC. 4.5X14MM BC CORKSCREW FT, DX; BIO SOFT TISSUE FIXATN FASTNR

Model Number	4.5X14MM BC CORKSCREW FT, DX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2026
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 (b)(6) 2026, it was reported by an arthrex employee via email that for ar-8927bc serial no (b)(6) corkscrew broke upon insertion.This was detected during use in surgical fixation right ankle fracture procedure on (b)(6) 2026.The procedure was completed successfully with the use of another anchor and no fragments retained in the patient¿s body.

• Brand Name: 4.5X14MM BC CORKSCREW FT, DX
• 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: 24176646
• Report Number: 1220246-2026-00304
• Device Sequence Number: 10017259
• Product Code: MAI
• UDI-Device Identifier: 00888867131521
• UDI-Public: (01)00888867131521(11)250903(17)290831(10)15492776
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 4.5X14MM BC CORKSCREW FT, DX
• Device Catalogue Number: AR-8927BC
• Device Lot Number: 15492776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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