MAUDE Adverse Event Report: ARTHREX, INC. STRAIGHT PLATE, 2.4MM, 6 HOLE,REINFORCED; BONE FIXATION PLATE

Model Number	STRAIGHT PLATE, 2.4MM, 6 HOLE,REINFORCED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 12/5/2023, it was reported by a sales representative via (b)(4) that an ar-18724p-17 straight plate broke.The broken fragments were removed, and the case was completed successfully.This was discovered during a procedure on (b)(6) 2023.Additional information received on 12/11/2023: this was discovered during a talus and ankle fracture procedure and completed using an ar-18724p-10 t-plate, 2.4 mm, 6 hole.The case was only briefly delayed, and no additional anesthesia was administered.The patient suffered no negative effect on or after the procedure.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.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.Per dfu-0192-eo rev 6 g precautions - 4.Repeated bending of the plate at the same location, or by creating excessive acute angles may potentially lead to premature plate fatigue, failure and or breakage in situ.The most likely cause for the reported failure can be a user error due to improper device technique.

• Brand Name: STRAIGHT PLATE, 2.4MM, 6 HOLE,REINFORCED
• 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: emily shafer ; 8009337001
• MDR Report Key: 18431443
• Report Number: 1220246-2024-00026
• Device Sequence Number: 7867387
• Product Code: HRS
• UDI-Device Identifier: 00888867314368
• UDI-Public: 00888867314368
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K220937
• 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): 01/28/2025

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: STRAIGHT PLATE, 2.4MM, 6 HOLE,REINFORCED
• Device Catalogue Number: AR-18724P-17
• Device Lot Number: 5262323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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