MAUDE Adverse Event Report: ARTHREX, INC. BB-TAK, THREADED; ORTHOPEDIC MANUAL SURG INSTR

Model Number	BB-TAK, THREADED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2026
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 17-jan-2026, a facility representative reported via (b)(4) that an ar-13226t bb-tak threaded rod screw broke off while the surgeon was removing it from the plate, and the tip remained in the patient and could not be retrieved during an ankle syndesmotic repair.The procedure was successfully completed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on photographic evidence of a fractured ar-13226t.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as off-axis loading and prying and leveraging the device during use.

• Brand Name: BB-TAK, THREADED
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 24291873
• Report Number: 1220246-2026-00472
• Device Sequence Number: 13113621
• Product Code: LXH
• UDI-Device Identifier: 00888867010123
• UDI-Public: 00888867010123
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: BB-TAK, THREADED
• Device Catalogue Number: AR-13226T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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