MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE LOCKING SCREW 3.5 MM X 30 MM; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE LOCKING SCREW 3.5 MM X 30 MM
Medical Device Problem Codes	Positioning Failure (1158); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/01/2024, it was reported by an arthrex subsidiary employee via e-mail that an ar-8935l-30s low profile locking screw was not engaging the locking hole of the plate and was spinning.This occurred during the contemplative repair and fixation procedure using a calcaneal fracture plate (ar-8954yl-ss).Drilling was performed using an ar-8935gv (variable drill guide) and an ar-8943-42 (2.5 mm drill) and a plate fixation screw when the screw was not engaging the locking hole of the plate and was spinning.They replaced the screw and used an ar-8935l-28s to complete the case, which was implanted without any problem.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is not confirmed.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 was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces and/or misaligned insertion.

• Brand Name: LOW PROFILE LOCKING SCREW 3.5 MM X 30 MM
• Common Device Name: BONE FIXATION SCREW/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: 18906173
• Report Number: 1220246-2024-01490
• Device Sequence Number: 18102692
• Product Code: HWC
• UDI-Device Identifier: 00888867051027
• UDI-Public: 00888867051027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: LOW PROFILE LOCKING SCREW 3.5 MM X 30 MM
• Device Catalogue Number: AR-8935L-30S
• Device Lot Number: 14951466
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2022
• 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