MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TRIAL POLY SZ 2+ 8MM SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	IB203208
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that during an "inbone / invision surgery planned for a sz 3 on the tibia and talar component.Surgeon changed to a size 2 talus intraoperatively.We didn't have the sz 2 plus inserts at the hospital and had to call them in.Surgeon proceeded to operate and tighten the lateral ligament's and was notified during that time that the smallest sz 8 spacer was not available in wa.The size 10 was on its way with a courier, yet he advised he would not fit the 10-insert in.As the 8 was not available he implanted the trial insert from the instrument set and closed the patient.He intends to bring them back in the revise at a later date.".
Additional Manufacturer Narrative
The complaint could be confirmed, because a surgeon reported a revision due to the implantation of an instrument.The current instructions for use state: "the surgical instrumentation is intended to be used by surgeons for the implantation and explantation of implants in orthopedic surgery.Caution: under no circumstances should an instrument be implanted." a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.Based on investigation, the root cause was attributed to a use related issue, off-label use.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that during an "inbone / invision surgery planned for a sz 3 on the tibia and talar component.Surgeon changed to a size 2 talus intraoperatively.We didn't have the sz 2 plus inserts at the hospital and had to call them in.Surgeon proceeded to operate and tighten the lateral ligament's and was notified during that time that the smallest sz 8 spacer was not available in wa.The size 10 was on its way with a courier, yet he advised he would not fit the 10-insert in.As the 8 was not available he implanted the trial insert from the instrument set and closed the patient.He intends to bring them back in the revise at a later date.".

• Brand Name: INBONE TRIAL POLY SZ 2+ 8MM 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: 23317234
• Report Number: 3010667733-2025-01181
• Device Sequence Number: 4851892
• Product Code: HSN
• UDI-Device Identifier: 00889797048248
• UDI-Public: 00889797048248
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100886
• 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): 12/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: IB203208
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female