MAUDE Adverse Event Report: ARTHREX, INC. ANKLE FUSION PLATE, ANTERIOR TT, RIGHT; BONE FIXATION PLATE

Model Number	ANKLE FUSION PLATE, ANTERIOR TT, RIGHT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/08/2021, it was reported by a sales representative via phone that an ar-8970ar anterior right ankle fusion plate, the screws would not lock into the plate correctly.The surgeon removed the plate and screws.This was discovered during an ankle fusion repair on (b)(6) 2021. the case was completed by using the 2nd ar-8970ar in the kit.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023. arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.The most likely cause for the reported failure can be attributed to improper bone prep and/or misaligned insertion.

• Brand Name: ANKLE FUSION PLATE, ANTERIOR TT, RIGHT
• 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: 19492745
• Report Number: 1220246-2024-05168
• Device Sequence Number: 12521902
• Product Code: HRS
• UDI-Device Identifier: 00888867133938
• UDI-Public: 00888867133938
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K141735
• 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
• Report Date (Section B): 06/07/2024

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: ANKLE FUSION PLATE, ANTERIOR TT, RIGHT
• Device Catalogue Number: AR-8970AR
• Device Lot Number: 5262018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2020
• 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