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

Model Number	ANKLE FUSION PLATE, LATERAL TT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 it was reported by sales rep via email that during a procedure on (b)(6) 2021 when surgeon attempted to place an eccentric screw into the oblong compression hole in an ar-8970tt ankle fusion plate, the 4.5mm cortical screw went thought the plate.A tissue protector/drill sleeve was used so the angle should not have been too steep.The surgeon ended up having to remove the plate to get the screw out and then plate was placed again.Additional information requested: 1.What lot#? 2.What new screw was used to replate?.
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.As no further investigation was able to be performed no change in harm was identified.

• Brand Name: ANKLE FUSION PLATE, LATERAL TT
• 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: 19228387
• Report Number: 1220246-2024-02693
• Device Sequence Number: 12265965
• Product Code: HRS
• UDI-Device Identifier: 00888867134003
• UDI-Public: 00888867134003
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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, LATERAL TT
• Device Catalogue Number: AR-8970TT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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