MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PROPHECY INBONE PATIENT SPECIFIC GUIDES; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	PROPINB
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a prophecy case, a severe mismatch was identified between the patient-specific inbone trial blocks and the patient¿s anatomy.Although the blocks, case numbers, patient name, and webops shipment information all aligned correctly, the blocks did not fit intraoperatively.A detailed review comparing the patient¿s original ct scan from the scanning facility to the native ct in the surgeon¿s pacs system confirmed that both accurately represented the patient¿s anatomy.However, the ct images displayed in the prophecy report reflected anatomy inconsistent with patient (b)(6) subsequent comparison with the patient¿s x-rays further confirmed that the ct used to build the prophecy report did not belong to this patient.This appears to be an extremely rare occurrence and raises concern that another mismatched scan and corresponding block set may exist.Verification and troubleshooting are needed to confirm the issue and prevent recurrence.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
Correction: h6 health code.The reported event was confirmed, since evaluation of the report and guide design does find the incorrect scans were uploaded and approved.The prophecy team conducted an investigation into the reported incident.According to their review, "originally, ct-scan files containing the incorrect leg side for the proper patient were identified and reported by the prophecy team.On a second attempt, new ct-scan files containing a right leg side were uploaded and used to create the prophecy plan but did not correspond to the appropriate patient." further investigation into the incident also determined that the rep did not create the cd that was uploaded.The cd with the scans was given directly to the rep by the surgeon or their collegue, and the rep uploaded them to the prophecy portal per normal procedure.It was also noted the surgeon reviewed the guides and scans and approved.Based on the investigation, the root cause was determined to be a user related issue.The failure was caused by the surgeon providing the wrong scans and approving them.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
During a prophecy case, a severe mismatch was identified between the patient-specific inbone trial blocks and the patient¿s anatomy.Although the blocks, case numbers, patient name, and webops shipment information all aligned correctly, the blocks did not fit intraoperatively.A detailed review comparing the patient¿s original ct scan from the scanning facility to the native ct in the surgeon¿s pacs system confirmed that both accurately represented the patient¿s anatomy.However, the ct images displayed in the prophecy report reflected anatomy inconsistent with patient r.F.Subsequent comparison with the patient¿s x-rays further confirmed that the ct used to build the prophecy report did not belong to this patient.This appears to be an extremely rare occurrence and raises concern that another mismatched scan and corresponding block set may exist.Verification and troubleshooting are needed to confirm the issue and prevent recurrence.

• Brand Name: PROPHECY INBONE PATIENT SPECIFIC GUIDES
• 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: 23623814
• Report Number: 3010667733-2025-01392
• Device Sequence Number: 18400116
• Product Code: HSN
• UDI-Device Identifier: 00889797057110
• UDI-Public: (01)00889797057110(11)250814(17)260214(10)1830113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110360
• 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): 03/05/2026

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 Expiration Date: 02/14/2026
• Device Catalogue Number: PROPINB
• Device Lot Number: 1830113
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male