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 Problems Device Difficult to Setup or Prepare (1487); Positioning Problem (3009)

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

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported that the custom-made guides didn't fit on the desired axis, and the planning position couldn't be achieved.We had to revert to a standard infinity.It was planned to be a tibia size 4 with a polyethylene of 4 and a talus of 4.The surgeon was still surprised when he finally implanted a tibia 3 with a polyethylene 2+ and a talus of 2.There was a delay of 90 minutes in the surgery.

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Upon further investigation by the prophecy team, the following were noted: ¿ 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.¿ from the prophecy operations perspective, all procedures were followed accordingly therefore, it is difficult to confirm if there was a problem in subsequent steps of the process or if the correct set of guides were delivered for this surgery.¿ the final implant sizes utilized for the patient could be different compared to the prophecy plan due to the use of standard instrumentation technique since alignment decisions taken intraoperatively might vary between the plan and decisions made by the surgeon.¿ a potential root cause related to the implant sizing discrepancy may be the standard instrumentation approach utilized in surgery.¿ another potential root cause could be that the wrong set of guides were delivered (as stated in the event description).Follow up on this potential root cause will be done.¿ finally, another alternative could be a discrepancy in user expectations vs guide fit and feel during surgery.The delivery process for the guides was reviewed by the prophecy team and the following was noted: "after reviewing our manufacture and shipping process with our teammates in charge of it, we have found no abnormalities about the delivering of the prophecy guides for this case." 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.

Event Description

It was reported that the custom-made guides didn't fit on the desired axis, and the planning position couldn't be achieved.We had to revert to a standard infinity.It was planned to be a tibia size 4 with a polyethylene of 4 and a talus of 4.The surgeon was still surprised when he finally implanted a tibia 3 with a polyethylene 2+ and a talus of 2.There was a delay of 90 minutes in the surgery.

• 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: 17824143
• MDR Text Key: 324342683
• Report Number: 3010667733-2023-00554
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2024
• Device Catalogue Number: PROPINFE
• Device Lot Number: 1764906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2023
• 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
• Patient Age: 62 YR
• Patient Weight: 83 KG