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	10/23/2025
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 10/23/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-13226ts threaded bbtak was used to temporarily fixate the plate in distal fibula fracture repair.When attempting to remove it, the surgeon noticed that the threads had broken and that a fragment had remained inside the body.This occurred during use in a case.As removal would be difficult, the fragment was left in place and the surgery was completed.No additional products were required to complete the surgery.The plate used was ar-9963apll-06s (lot number unknown).No photo is available.Type of the surgery was distal fibula fracture repair.No significant surgery delay reported.No additional anesthesia administered to the patient.No information about an instrument used to prepare/tap the bone socket for insertion of the implant.Bone quality of the patient is unknown.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 of the reported issue is use-related mechanical overstress during removal of the implant.

• 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: 23477164
• Report Number: 1220246-2025-05012
• Device Sequence Number: 10195833
• Product Code: LXH
• UDI-Device Identifier: 00888867198609
• UDI-Public: (01)00888867198609(11)250201(17)300131(10)5007155767
• 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): 03/05/2026

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: 5007155767
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown