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

Model Number PROPINB

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

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

Event Date 11/10/2022

Event Type  malfunction  

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.

Event Description

It was reported that the prophecy blocks did not fit patient.The surgical team was 100% sure it was correct blocks for the patient.The blocks sat to medial.The physician had to cut the blocks to make them work.

Manufacturer Narrative

Please note the correction made to the h6 device code: 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 complaint and conducted an internal investigation into their processing of these 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." 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 prophecy blocks did not fit patient.The surgical team was 100% sure it was correct blocks for the patient.The blocks sat to medial.The physician had to cut the blocks to make them work.

• Brand Name: PROPHECY INBONE 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: 15915799
• MDR Text Key: 304826717
• Report Number: 3010667733-2022-00427
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797057110
• UDI-Public: 00889797057110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110360
• 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: 05/03/2023

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: 04/06/2023
• Device Model Number: PROPINB
• Device Catalogue Number: PROPINB
• Device Lot Number: 1744162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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