MAUDE Adverse Event Report: ARTHREX, INC. LOCK DISTAL FIBULA PLT, SS LT, 8H; PLATE, FIXATION, BONE

Model Number	LOCK DISTAL FIBULA PLT, SS LT, 8H
Medical Device Problem Codes	Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2025
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 10/3/2025, it was reported by a sales representative via email that a 2.7 screw would not lock into an ar-8943dl-08 locking distal fibula plate.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 10/8/2025: it was confirmed that the 2.7 screw did not lock into three ar-8943dl-08 locking distal fibula plate during the ankle fixation surgery.When the plates were inspected, they did not have a stamp like the other plates of different size.The case was completed using a 10 hole tubular plate.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on photographic evidence of an ar-8943dl-08, batch 105642503, that displays the screw was not locking into the designated plate.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 the most likely cause.The most likely cause is an internal manufacturing issue, as the plate was not marked correctly.

• Brand Name: LOCK DISTAL FIBULA PLT, SS LT, 8H
• Common Device Name: PLATE, FIXATION, BONE
• 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: 23293174
• Report Number: 1220246-2025-04584
• Device Sequence Number: 4824283
• Product Code: HRS
• UDI-Device Identifier: 00888867346772
• UDI-Public: (01)00888867346772(11)250115(10)105642503
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123241
• 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): 02/03/2026

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: LOCK DISTAL FIBULA PLT, SS LT, 8H
• Device Catalogue Number: AR-8943DL-08
• Device Lot Number: 105642503
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown