MAUDE Adverse Event Report: ARTHREX, INC. CALIBRATED DRILL AO STYLE, 2.8MM X 95MM; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	CALIBRATED DRILL AO STYLE, 2.8MM X 95MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2024
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 11/04/2024, it was reported by a sales representative via (b)(4) that a 0318-200 drill guide and a 0237-200 calibrated drill became stuck.This occurred during a proximal humerus fx case.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged 0237-200 serial/batch number (b)(6) was received for evaluation.The devices arrived stuck for evaluation.Functional testing was not performed because the device arrived for evaluation stuck inside the 0318-200 drill guide, non-locking/locking, 2.8mm.A visual inspection revealed that the threaded shaft was bent, and the threads had nicks.The drill connector also had damage, such as nicks.The most likely cause of the device's reported and observed failure is user error, specifically misaligned insertion and/or prying/levering the device during insertion.

• Brand Name: CALIBRATED DRILL AO STYLE, 2.8MM X 95MM
• Common Device Name: FIXATN NAIL/BLADE/PLATE COMBO
• 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: 20820876
• Report Number: 1220246-2024-08685
• Device Sequence Number: 8843676
• Product Code: KTW
• UDI-Device Identifier: 00848665032277
• UDI-Public: (01)00848665032277(11)230202(10)220188
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K080590
• 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): 01/30/2025

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: CALIBRATED DRILL AO STYLE, 2.8MM X 95MM
• Device Catalogue Number: 0237-200
• Device Lot Number: 220188
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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