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

Model Number	BB-TAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 1/23/2024, it was reported by a sales representative via email that an ar-13226 bb tak tip broke off under an ar-8958-01 two-hole plate during the removal of the ar-13226 bb tak.This issue did not delay the case as it will stay in until the ar-8958-01 two-hole plate for the maisonneuve is removed.The surgeon did not appear to leverage the tip of the ar-13226 bb tak on the ar-8958-01 two-hole plate.This was discovered during a maisonneuve fracture procedure (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure is user error, specifically excessive force and/or leveraging during the removal of the device.The complaint allegation was confirmed based on the customer's attached picture, which shows the shaft broken on the plate.

• Brand Name: BB-TAK
• 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: 18680409
• Report Number: 1220246-2024-00898
• Device Sequence Number: 6194929
• Product Code: LXH
• UDI-Device Identifier: 00888867010116
• UDI-Public: 00888867010116
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/21/2025

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
• Device Catalogue Number: AR-13226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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