MAUDE Adverse Event Report: ARTHREX, INC. LOW PRO T-PLATE, 2.4 MM, 5 HOLE, STERILE; BONE FIXATION PLATE

Model Number	LOW PRO T-PLATE, 2.4 MM, 5 HOLE, STERILE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
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 12/01/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8952mt-05s low-profile t-plate locking screws 2 and 4 did not lock in the screw holes on the right side of the distal t-shaped section.No variable guide was used; regular instruments and a regular drill were used.The plate was removed from the body, and a different screw was opened on the instrument table.Various screws were tried, but none locked.Another plate was opened, and the same locking screw was tried in the same screw hole.The case was completed using another plate.No photo is available.No detailed information about the type of surgery.No significant surgery delay reported.Nothing remains in the patient.No additional anesthesia was administered to the patient.The bone quality of the patient is unknown.No adverse patient effects have been reported during or following the procedure due to this issue.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a user error, including improper bone preparation and/or improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: LOW PRO T-PLATE, 2.4 MM, 5 HOLE, STERILE
• 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: 23876083
• Report Number: 1220246-2025-05764
• Device Sequence Number: 4669072
• Product Code: HRS
• UDI-Device Identifier: 00888867204164
• UDI-Public: (01)00888867204164(11)240820(17)290731(10)15305380
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150456
• 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
• Report Date (Section B): 03/31/2026

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 PRO T-PLATE, 2.4 MM, 5 HOLE, STERILE
• Device Catalogue Number: AR-8952MT-05S
• Device Lot Number: 15305380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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