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

Catalog Number	PROPINF
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional 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 in a supplemental report.
Event or Problem Description
As reported: "(b)(4) fw: infinity prophecy talus.The talus pins are consistently high (too proximal) when using the prophecy guides.The surgeon ends up with a smaller footprint than expected for the talus implant, and they've frequently had a tighter fit than expected due to the smaller footprint.".
Event or Problem Description
As reported: "(b)(4): infinity prophecy talus.The talus pins are consistently high (too proximal) when using the prophecy guides.The surgeon ends up with a smaller footprint than expected for the talus implant, and they've frequently had a tighter fit than expected due to the smaller footprint.".
Additional Manufacturer Narrative
Please note corrections to d4 (catalog #, lot #, and gtin).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The prophecy team was made aware of the allegation and conducted an internal review into their processes for these patient specific guides.According to their review, "the ct scan was processed within normal, acceptable ranges.No errors were identified during the segmentation procedure.The alignment guides were designed within normal, acceptable ranges.No abnormalities in the internal process were found.The engineering drawings and quality documents were processed within normal, acceptable ranges.No abnormalities in the internal process were found.The preference to resect an extra 1 mm on the talus requested by surgeon and rep was included in the system.It was not possible to identify what caused the prophecy talus guide pin placement mentioned in the complaint¿s email.A potential root cause may be a discrepancy in user expectations vs standard guide design or user error during surgery." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.

• Brand Name: PROPHECY INFINITY 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20951838
• Report Number: 3010667733-2024-01067
• Device Sequence Number: 15372414
• Product Code: HSN
• UDI-Device Identifier: 00889797057134
• UDI-Public: 00889797057134
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131283
• 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): 03/14/2025

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 Expiration Date: 02/21/2025
• Device Catalogue Number: PROPINF
• Device Lot Number: 1797023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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