MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TRIAL POLY SZ 2+ 10MM SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	IB203210
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The poly trials would disengage when the doctor would try to fully seat them into the tibial tray dove tails.All precautionary actions were taken to ensure nothing was impeding the poly trial from seating correctly.The physician believes the machining of the dove tails on the tibial tray were not even on both sides.Specifically the lateral side dove tail was more parallel (up and down) than the medial side, which seemed to have more of an angled cut.Final poly implant was able to seat with minimal complications.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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 material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If the device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The poly trials would disengage when the doctor would try to fully seat them into the tibial tray dove tails.All precautionary actions were taken to ensure nothing was impeding the poly trial from seating correctly.The physician believes the machining of the dove tails on the tibial tray were not even on both sides.Specifically the lateral side dove tail was more parallel (up and down) than the medial side, which seemed to have more of an angled cut.Final poly implant was able to seat with minimal complications.

• Brand Name: INBONE TRIAL POLY SZ 2+ 10MM SULCUS
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23717296
• Report Number: 3010667733-2025-01462
• Device Sequence Number: 10401403
• Product Code: HSN
• UDI-Device Identifier: 00889797048255
• UDI-Public: (01)00889797048255(11)240207(10)3006320
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: IB203210
• Device Lot Number: 3006320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown