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

Model Number 200009902

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

It was reported that the surgeon opened the implant into the sterile field and noted that it did not have plasma spray coating on it.The surgeon did not use the implant and opened up a backup implant which had the plasma spray coating and used it instead.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not available.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned and did not have the plasma coating as intended.Device inspection revealed the following: visual inspection of the returned device confirms the product to be catalog #: 200009902 ; inbone stem, tibial, base size, 18 mm, right & left ; lot/serial #: 1716575.Examination also confirms the plasma coating is missing around the entire medial section of the implant.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.A non conformance report has been initiated to address this event a further investigate the problem.

Event Description

It was reported that the surgeon opened the implant into the sterile field and noted that it did not have plasma spray coating on it.The surgeon did not use the implant and opened up a backup implant which had the plasma spray coating and used it instead.

• Brand Name: INBONE¿ TOTAL ANKLE SYSTEM
• Type of Device: 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 13118900
• MDR Text Key: 285828943
• Report Number: 3010667733-2021-00028
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420123848
• UDI-Public: 00840420123848
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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
• Device Operator: Health Professional
• Device Model Number: 200009902
• Device Catalogue Number: 200009902
• Device Lot Number: 1716575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1