MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,36MM LGTH; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,2.5 MICRO,36MM LGTH
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2024
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 12/28/2024 it was reported by a sales representative via sems-(b)(4) that an ar-8725-36h compr ft screw stripped.The bone and screw had to be shortened.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is a user error, due to improper bone preparation or misalignment of the insertion.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: COMPR FT SCRW,2.5 MICRO,36MM LGTH
• 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: 21217799
• Report Number: 1220246-2025-00051
• Device Sequence Number: 8786161
• Product Code: HWC
• UDI-Device Identifier: 00888867303270
• UDI-Public: 00888867303270
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• 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): 08/28/2025

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: COMPR FT SCRW,2.5 MICRO,36MM LGTH
• Device Catalogue Number: AR-8725-36H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2024
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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