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	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient exhibited significant misalignment of tibial blocks for unknown reasons.The scans were conducted on (b)(6), 2023, and surgery performed on (b)(6), 2023.
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that a patient exhibited significant misalignment of tibial blocks for unknown reasons.The scans were conducted on (b)(6) 2023, and surgery performed on (b)(6) 2023.
Additional 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 was 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.No root cause identified: it was not possible to identify what caused the tibia prophecy block inaccuracy mentioned in the complaint¿s email.A potential root cause may be a discrepancy in user expectations vs guide fit and feel during surgery or user error during surgery.Another potential root cause could be potential changes in patient anatomy between the scan date and the surgery date.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.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17497504
• Report Number: 3010667733-2023-00431
• Device Sequence Number: 6375059
• Product Code: HSN
• UDI-Device Identifier: 00889797057134
• UDI-Public: 00889797057134
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K110360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: 09/10/2023
• Device Catalogue Number: PROPINF
• Device Lot Number: 1756063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male