MAUDE Adverse Event Report: ARTHREX, INC. FHL IMPLANT SYSTEM, 6.25 MM; BONE FIXATION SCREW/PLATE

Model Number	FHL IMPLANT SYSTEM, 6.25 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
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 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 error of the device due to excessive force being used during insertion of the screw.
Event or Problem Description
On 07/22/2025, a sales representative reported via sems (b)(4) that an ar-1562bc-cp fhl implant systems screw broke.This occurred during a case when the surgeon went to advance the tenodesis screw the screw broke.They were able to remove it, discard and replace it with another.There were no adverse effects to the patient or procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: FHL IMPLANT SYSTEM, 6.25 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: 22793242
• Report Number: 1220246-2025-03463
• Device Sequence Number: 8808721
• Product Code: HWC
• UDI-Device Identifier: 00888867315174
• UDI-Public: 00888867315174
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• 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): 12/12/2025

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: FHL IMPLANT SYSTEM, 6.25 MM
• Device Catalogue Number: AR-1562BC-CP
• Device Lot Number: 15034790
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown