MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE POLY SZ 4+ 10MM SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 220225410E

Device Problems Positioning Failure (1158); Mechanical Jam (2983)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.

Event Description

It was reported that the patient presented for a primary total ankle replacement.When inserting the poly it would not go in.We removed the inserter and used the poly impactor and it still would not go in and the poly was pulling the tibial tray downwards.The surgeon felt that the lip of the poly was thicker than usual.The surgeon needed to alter the poly with a 15 blade to get it to go in to the tray.There was a surgical delay of 20 minutes.

Manufacturer Narrative

Correction - d5 operator of device.The reported event could not be confirmed since the device was not returned and imaging provided did not allow for identification of a root cause.The surgical procedure does note ,"to prevent incomplete seating of the poly insert, properly irrigate the tibial tray prior to poly insertion.Apply slight ¿reaction force¿ as necessary to keep insertion tool at 90° to tibia." no units from this lot were available in stock to examine for dimensional or functional defects.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 review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient presented for a primary total ankle replacement.When inserting the poly it would not go in.We removed the inserter and used the poly impactor and it still would not go in and the poly was pulling the tibial tray downwards.The surgeon felt that the lip of the poly was thicker than usual.The surgeon needed to alter the poly with a 15 blade to get it to go in to the tray.There was a surgical delay of 20 minutes.

• Brand Name: INBONE POLY SZ 4+ 10MM SULCUS
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18060232
• MDR Text Key: 327216720
• Report Number: 3010667733-2023-00657
• Device Sequence Number: 1
• Product Code: HSN
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 220225410E
• Device Lot Number: 1696445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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