MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM TIBIAL BASE SIZE 18MM RIGHT AND LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 200009902

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

During an inbone total ankle replacement procedure, the 18mm base stem failed to thread into the other implants due to imperfections in its threads.Despite this setback, the surgery was successful as a backup 18mm base was used instead.The returned product will undergo examination to identify the flaw in the base stem.

Manufacturer Narrative

The reported event was confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual examination of the returned device confirms the size and lot number.Scratches can be seen on the inferior surface of the device.The external threads of the device were confirmed to be defective upon failing a feature check with a thread gage.The device could not pass dimensional verification as it was unable to thread into the thread gage.Based on investigation, the root cause was attributed to a manufacturing related issue.A nonconformance was opened to further address the issue.

Event Description

During an inbone total ankle replacement procedure, the 18mm base stem failed to thread into the other implants due to imperfections in its threads.Despite this setback, the surgery was successful as a backup 18mm base was used instead.The returned product will undergo examination to identify the flaw in the base stem.

• Brand Name: INBONE STEM TIBIAL BASE SIZE 18MM RIGHT AND LEFT
• 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: 18411248
• MDR Text Key: 331531312
• Report Number: 3010667733-2023-00815
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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: 200009902
• Device Lot Number: 1751953
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• 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