MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW, CANN, BLUNT TIP, 4 X 36 MM; SMOOTH FIXATION PIN

Model Number	LO-PRO SCRW, CANN, BLUNT TIP, 4 X 36 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2025
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 (b)(6) 2025, a sales representative reported via phone that an ar-5051-36 low profile screw was being advanced by hand and the screw head broke off of the shaft.This was discovered during a case.An additional hour was added to the case.The facility needed a sterile transfer for a screw removal set.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure can be attributed to user error due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device.Additionally, the use of a cannulated driver handle is always recommended.The complaint allegation was confirmed based on the customer's attached picture, where a screw was displayed broken off.

• Brand Name: LO-PRO SCRW, CANN, BLUNT TIP, 4 X 36 MM
• Common Device Name: SMOOTH FIXATION PIN
• 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: 21311469
• Report Number: 1220246-2025-00185
• Device Sequence Number: 8083814
• Product Code: HTY
• UDI-Device Identifier: 00888867217591
• UDI-Public: 00888867217591
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: LO-PRO SCRW, CANN, BLUNT TIP, 4 X 36 MM
• Device Catalogue Number: AR-5051-36
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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