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
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• 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: 18411248
• Report Number: 3010667733-2023-00815
• Device Sequence Number: 15630964
• Product Code: HSN
• UDI-Device Identifier: 00840420123848
• UDI-Public: 00840420123848
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 200009902
• Device Lot Number: 1751953
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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