MAUDE Adverse Event Report: ARTHREX, INC. DRILL GUIDE, NON-LOCKING/LOCKING, 2.8MM; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	DRILL GUIDE, NON-LOCKING/LOCKING, 2.8MM
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 (b)(6) 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
Complaint allegation is confirmed.One unpackaged 0318-200 serial/batch number (b)(6) was received for evaluation.Functional testing was not performed because the device arrived for evaluation with a drill stuck in one of the guide holes.A visual inspection revealed that the part 0237-200 calibrated drill ao style, 2.8mm x 95mm was stuck in one of the guide holes.It was also noted that damaged like nicks all around the device.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: DRILL GUIDE, NON-LOCKING/LOCKING, 2.8MM
• 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: 20820700
• Report Number: 1220246-2024-08684
• Device Sequence Number: 7683371
• Product Code: KTW
• UDI-Device Identifier: 00848665032284
• UDI-Public: (01)00848665032284(11)220414(10)220162
• 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: DRILL GUIDE, NON-LOCKING/LOCKING, 2.8MM
• Device Catalogue Number: 0318-200
• Device Lot Number: 220162
• 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: 04/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown