MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM SS 2.7X 18MMCORTEX; BONE FIXATION PLATE

Model Number	LO-PRO SCRW TM SS 2.7X 18MMCORTEX
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
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 email that a patient underwent revision surgery due to pain.On (b)(6) 2023, the patient underwent surgery for an ankle fracture and syndesmosis repair.During the procedure, two ar-8730-36pt low profile screw, ti, 3.0 mm x 36 mm, cancellous, partially threaded, an ar-8827-18 low profile screw, 2.7 x 18 mm, cortex, an ar-8827-22 low profile screw, 2.7 x 22 mm, cortex, an ar-8973ds fibulock implant system, an ar-8973l-38-180 arthrex fibulock nail, 3.8 x 180 mm left, and an ar-8925ss syndesmosis tightrope xp, stainless steel were implanted.Post-operative, the patient started to experience pain.On (b)(6) 2024, revision surgery was performed to remove all the implants except for the ar-8973l-38-180 arthrex fibulock nail.During the removal of the implants, the distal end of the extraction tool of an ar-8973rk fibulock removal kit broke off after roughly 8 mallet strikes.Another ar-8973rk fibulock removal kit was opened, and the same thing occurred.The extraction tools broke, but no pieces were in the patient.The surgeon elected to close and finish the case with the nail still implanted and felt confident that the removed products would help with the patient¿s complaints.
Additional Manufacturer Narrative
Additional information: g3, h5, 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 a patient-specific event.

• Brand Name: LO-PRO SCRW TM SS 2.7X 18MMCORTEX
• Common Device Name: BONE FIXATION 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: 20156936
• Report Number: 1220246-2024-07414
• Device Sequence Number: 4247729
• Product Code: HRS
• UDI-Device Identifier: 00888867046771
• UDI-Public: 00888867046771
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW TM SS 2.7X 18MMCORTEX
• Device Catalogue Number: AR-8827-18
• Device Lot Number: 14932294
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown