MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 20MMCORT; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW TM,SS 3.5X 20MMCORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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 (b)(6) 2024, it was reported by a sales representative via phone that an ar-8835-20 low profile screw head broke off.This occurred during an ankle fracture on (b)(6) 2024 when the screw was inserted into the bone, the screw head broke off.The fragment was able to be retrieved.The patient had an average bone.A drill was used to prep the bone.This resulted in a delay of 10-12 minutes.It is unknown if additional anesthesia was administered.The case was completed using another ar-8835-20.There was 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 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.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 20MMCORT
• 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: 20620077
• Report Number: 1220246-2024-08430
• Device Sequence Number: 20670888
• Product Code: HWC
• UDI-Device Identifier: 00888867047310
• UDI-Public: 00888867047310
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K203239
• 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): 07/07/2025

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 TM,SS 3.5X 20MMCORT
• Device Catalogue Number: AR-8835-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 07/07/2025
• 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