MAUDE Adverse Event Report: ARTHREX, INC. 1.5MM GUIDE PIN; BONE FIXATION PLATE

Model Number	1.5MM GUIDE PIN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2025
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 03/28/2025, it was reported by a sales representative via (b)(4) that (qty.2) of a 0250-000 calibrated drill broke during use while being used in a regular fashion.Then, a 0109-150 1.5mm guide pin broke during use while trying to be removed in a regular fashion, and the broken piece was not able to be removed from the patient.The case was completed successfully.This occurred during a reverse total shoulder revision procedure on (b)(6) 2025.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the provided information, including the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error, specifically misuse of the device.The complaint allegation was not confirmed as the device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: 1.5MM GUIDE PIN
• Common Device Name: BONE FIXATION PLATE
• 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: 21866966
• Report Number: 1220246-2025-01584
• Device Sequence Number: 20807970
• Product Code: LXH
• UDI-Device Identifier: 00848665000108
• UDI-Public: 00848665000108
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/27/2025

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: 1.5MM GUIDE PIN
• Device Catalogue Number: 0109-150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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