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 Codes	Off-Label Use (1494); Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
This event is reportable due to the product mix in the central sterile processing which resulted in the wrong guides being used in the patient.
Additional Manufacturer Narrative
The reported event, alleged of issue was confirmed based on information received from the sales representative.Based on investigation, the root cause was attributed to a user related issue.As noted by the sales representative, the failure was caused by a processing error by the facilities sterilization department.The prophecy guides were labeled with the incorrect patient information during central sterilization and mixed-up with guides for a different surgical procedure as a result.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this timea review of the labeling did not indicate any abnormalities.¿ the instructions for use were reviewed and states: "markings on guides and models provide case identifiers, such as case number, and must be legible.Before using the guides and models, check the identifier and confirm that it corresponds with the current case.Do not use the guide or the model if the case identifiers are not legible." ¿ 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
This event is reportable due to the product mix in the central sterile processing which resulted in the wrong guides being used in the patient.

• 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.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17556086
• Report Number: 3010667733-2023-00443
• Device Sequence Number: 14672515
• 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
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/24/2024
• Device Catalogue Number: PROPINF
• Device Lot Number: 1740065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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: Male