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

Catalog Number PROPINF

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2023

Event Type  malfunction  

Event Description

It was reported that the blocks for the case were made for a right ankle when the case was for a left ankle.This was due to the scans that were uploaded were for the right ankle and were confirmed via email that the leg side on the scans was correct.The surgery was completed by using the standard instrumentation.No patient complications were reported.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device not available.

Event Description

It was reported that the blocks for the case were made for a right ankle when the case was for a left ankle.This was due to the scans that were uploaded were for the right ankle and were confirmed via email that the leg side on the scans was correct.The surgery was completed by using the standard instrumentation.No patient complications were reported.

Manufacturer Narrative

Correction:d1, d4 part and lot h6 results and conclusion codes.The reported event could be confirmed, since evaluation of the prophecy report and processes confirm they were created for a right ankle and not the left.The prophecy team was made aware of the complaint and conducted an internal investigation into the allegation.According to their asssessment, "the ct scan was processed within normal, acceptable ranges.No errors were identified during the procedure.The prophecy team requested via email from (b)(6) 2023 to confirm the leg side due to the discrepancy found between the information in the scans and the one present in the prophecy case management system ( as a normal procedure.The sales representative confirmed on the same day that the leg side from the scans provided (right side) were correct.However, the scans needed for this surgery corresponded to the left side (as indicated originally in the pcms).After this confirmation, the case was processed with the right side, but without updating the information about leg side in the pcms since the prophecy team is not able to update this field, and the sales representative was not aware of this discrepancy until surgery.The case was approved by the surgeon who also did not detect the error.The sales representative believed the leg side in the pcms would match the one in the scans if they were confirmed to be the correct side.The sales representative mentioned in an email from (b)(6) 2023 that he relies on the scans and the surgeon review when approving a case.Nevertheless, the correct side needs to be updated by the representative manually, since this information can only be changed by him.This was clarified in an email from (b)(6) 2023.When reviewing the raw data for this case, the scans available that were uploaded to the prophecy website showed the complete right leg and an incomplete scanned left side that would have been rejected by the prophecy ct scan protocol complete scans for the left side were not found.Human error during confirmation from the field for the correct leg side to process for this case." 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 more information is provided, the case will be reassessed.

• Brand Name: PROPHECY INFINITY PATIENT SPECIFIC GUIDES
• 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: 17240070
• MDR Text Key: 318265252
• Report Number: 3010667733-2023-00360
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797057134
• UDI-Public: 00889797057134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

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 Expiration Date: 11/08/2023
• Device Catalogue Number: PROPINF
• Device Lot Number: 1760886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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