MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE LOCKING SCREW 3.5 MM X 26 MM; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE LOCKING SCREW 3.5 MM X 26 MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
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 05/30/2025, an arthrex employee reported via email that an ar-8935l-26s low profile locking screw was used with an ar-8954pr-xss calcaneal fracture perimeter plate.Upon attempted use, the screw did not fit into the thread of the plate's locking hole, prompting redrilling and a second attempt at installation, which also proved unsuccessful.To complete the case, another ar-8935l-26s low profile locking screw was used successfully.There was no reported patient harm.This issue was discovered during an internal fixation open reduction procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 06/25/2025: there were no reports of any device breakage inside the patient.The procedure proceeded without delay, and no additional anesthesia was administered.The ar-8943-42 was used to prepare the bone socket for implant insertion, and the patient's bone quality was assessed as normal.Additional information was received on 07/02/2025: the correct plate part used in the procedure was ar-8954pl-xss calcaneal fracture perimeter plate from lot 15040619.
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 misaligned insertion and/or excessive forces being used during insertion of the screw.

• Brand Name: LOW PROFILE LOCKING SCREW 3.5 MM X 26 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: 22297736
• Report Number: 1220246-2025-02592
• Device Sequence Number: 9244398
• Product Code: HWC
• UDI-Device Identifier: 00888867050983
• UDI-Public: (01)00888867050983(11)240812(17)290731(10)15300999
• 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,Followup
• Report Date (Section B): 10/14/2025

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 26 MM
• Device Catalogue Number: AR-8935L-26S
• Device Lot Number: 15300999
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 10/08/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/24/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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