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

Catalog Number PROPINFE

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported that the guides did not fit.The surgery was completed successfully with no impact to the patient.

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but a similar device, part #propinf, is commercially available cleared 510k k131283.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

It was reported that the guides did not fit.The surgery was completed successfully with no impact to the patient.

Manufacturer Narrative

The complaint could be confirmed, since the information for evaluation matches the alleged failure.Prophecy team reviewed the received information and noted: conclusions: ¿ a partially attached body located anterior to the tibia was segmented incorrectly as a loose body.¿ in consequence, the tibia alignment guide was designed for a reference that did not consider the attached body.Therefore, the alignment guide surface match was affected.¿ in addition, the prophecy plan stated: ¿for the purposes of guide placement, the fragment is intended to be left intact.¿ according to the ct`s this is correct; however, this generated confusion because the body was segmented as ¿a loose body¿ and the alignment guide did not account for the presence of the attached fragment.¿ in summary, the attached body anterior to the tibia was segmented inappropriately as a loose body.Root cause identified: ¿ the tibia bone model was segmented without the attached body due to human error.The segmentation reviewer agreed on this decision during the "le prophecy® image segmentation review¿.However, after further investigation the body needed to be segmented as part of the tibia.¿ additionally, the body was reported incorrectly, showing a loose body in the image, but reported as a partially attached in the text due to human error.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device not returned.

• Brand Name: PROPHECY INFINITY EU 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: 18351899
• MDR Text Key: 331066112
• Report Number: 3010667733-2023-00792
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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: 04/24/2024
• Device Catalogue Number: PROPINFE
• Device Lot Number: 1773409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• 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