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

Model Number	ANKLE FUSION PLATE, LATERAL TTC
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling (2091)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported the patient had an ankle fusion on (b)(6) 2019 and the patient experienced pain and swelling had a follow up x-ray at the end of (b)(6) that revealed the ar-8970ttc, ankle fusion plate, was broken.Lot number of the plate was unknown at the time of initial report.The patient had to wait until june to have a revision surgery to remove the broken plate and screws.The doctor used a revision ankle subtalar fusion to remedy the situation.The patient is currently in a cast and in a healing state.Additional information obtained 7/20/2020: the original procedure was a ttc fusion on (b)(6) 2019.The revision surgery took place on (b)(6) 2020.The revision was completed using a nail.The surgeon has the plate and screws and will return them to arthrex for evaluation.The patient suffered no known trauma since the original procedure.Both original and revision procedures were performed by the same surgeon at the same facility.Screw part numbers are not known at this time.Additional information obtained 7/21/2020: the following are the devices originally implanted (b)(6) 2019.The surgeon chose to remove all of the below devices during the revision surgery: ar-8970ttc, ankle fusion plate lateral, lot 6791444.Ar-8545-40, low profile screw, lot 10184335.Ar-8545-44, low profile screw, lot 10265231.Ar-8545l-24, low profile locking screw, lot 1050683.Ar-8545l-28, low profile locking screw, lot 1042333.Ar-8545l-30, low profile locking screw, lot 1051302.Ar-8545l-32, low profile locking screw, lot 1014160.Ar-8545l-38, low profile locking screw, lot 1050682.Ar-8967-1840, low profile screw, lot 031739.Ar-8970-09, large bb-tak, lot 819784873.Ar-8970-09, large bb-tak, lot 900849548.Ar-8970-09t, large bb-tak threaded, lot 021443.
Additional Manufacturer Narrative
Complaint confirmed, the plate was found to be broken in two.The device and screws returned exhibited surface damage that likely occurred during removal.No bending deformation was observed on the plate.Review of the devices and x-ray provided suggest a likely cause of the event is non-union of the joint.

• Brand Name: ANKLE FUSION PLATE, LATERAL TTC
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10309706
• Report Number: 1220246-2020-01969
• Device Sequence Number: 952234
• Product Code: HRS
• UDI-Device Identifier: 00888867134010
• UDI-Public: 00888867134010
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ANKLE FUSION PLATE, LATERAL TTC
• Device Catalogue Number: AR-8970TTC
• Device Lot Number: 6791444
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/05/2014
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other