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

Model Number	BB-TAK, THREADED, STRL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/05/2026
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 05-jan-2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-13226ts bb-tak tip broke while fixing the plate.The broken tip could not be retrieved.This occurred during use in a orif case with no patient effect.No delay in case.

• Brand Name: BB-TAK, THREADED, STRL
• 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: 24114821
• Report Number: 1220246-2026-00247
• Device Sequence Number: 21256899
• Product Code: LXH
• UDI-Device Identifier: 00888867198609
• UDI-Public: (01)00888867198609(11)250601(17)300531(10)5105159234
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 05/13/2026

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, STRL
• Device Catalogue Number: AR-13226TS
• Device Lot Number: 5105159234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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