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

Model Number 220222210E

Device Problem Inaccurate Information (4051)

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

Event Date 05/12/2021

Event Type  malfunction  

Event Description

It was reported that upon opening of the device package it was noticed that the implant was larger than the trial.Upon inspection of the implant it was found that the device was a different size than what was on the label.The surgeon used a different size implant to complete the procedure.

Manufacturer Narrative

The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination shows the implants have part number 220223214e but the labeling has 220222210e.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A non-conformance report had been opened in order to further investigate no indications of manufacturing or design related problems were found during the investigation.A review of the labeling did indicate an abnormality.If any further information is provided, the complaint report will be updated.

• Brand Name: INBONE¿ TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• 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: 12775633
• MDR Text Key: 280510281
• Report Number: 0001043534-2021-00217
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420124968
• UDI-Public: 00840420124968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/08/2021

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: 220222210E
• Device Catalogue Number: 220222210E
• Device Lot Number: 05113580751661825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 89007
• Patient Sequence Number: 1