MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	200009902
Medical Device Problem Codes	Off-Label Use (1494); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the base stem did not have the plasma spray coating.The surgeon felt comfortable enough to use the implant in the patient.
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since previous complaints have been logged confirming the allegation of missing plasma spray.Based on investigation, the root cause was attributed to manufacturing related issue.The failure was caused by a vendor not applying the plasma coating as intended and an inspector failing to identify this issue at incoming inspection.There has been a nonconformance investigation into the allegation of missing plasma coating.Given that the plasma coating is optional, the product can still execute its intended use without the plasma coating.If the non-conforming product was implanted, the associated risk would defer to the associated risks of the smooth design stems.Additionally, the plasma coating does not dictate the overall diameter of the stem.The coating is within the boundaries of an 18 mm diameter dictated by the machined portions of the stem prior to coating.Overall diameter of the device, and therefore, overall fit of the device in the tibia, should not be affected.Therefore, there are no unknown or new risks associated with this event.The surgeon was aware of the missing plasma coating, but felt comfortable implanting with a 4 piece stem construct.
Event or Problem Description
It was reported that the base stem did not have the plasma spray coating.The surgeon felt comfortable enough to use the implant in the patient.

• Brand Name: INBONE¿ TOTAL ANKLE SYSTEM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15260350
• Report Number: 0001043534-2022-00002
• Device Sequence Number: 6710695
• Product Code: HSN
• UDI-Device Identifier: 00840420123848
• UDI-Public: 00840420123848
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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: 200009902
• Device Catalogue Number: 200009902
• Device Lot Number: 1716575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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