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

Catalog Number	PROPINV
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the revision procedure the invision guides did not fit and the surgeon had to use the foot holder to complete the procedure.Update aug 12/24: case was completed successfully with the inbone frame.No adverse consequences, medical intervention.Delay of approximately 2 hours.
Additional Manufacturer Narrative
Based on the available information the device was discarded and will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that during the revision procedure the invision guides did not fit and the surgeon had to use the foot holder to complete the procedure.Update aug 12/24: case was completed successfully with the inbone frame.No adverse consequences, medical intervention.Delay of approximately 2 hours.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence 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.The candidate for prophecy invision email was sent by the prophecy team because the initial case99411 was created under infinity technology and the patient presented existing implants, then the initial case was switched to invision technology.In the email communication, it was mentioned that because of the complexity of prophecy invision cases, the lead time is currently 5 weeks from the case creation date, but the actual lead time for cases from canada is 6 weeks.Nevertheless, between the case creation date (29-may-2024) and the date of surgery set by the sales representative/surgeon ((b)(6) 2024) there was 8 weeks.As an internal prophecy procedure, the invision surgery date was set to match the surgery date from the initial case99411 ((b)(6) 2024).According to prophecy protocol, the scans are acceptable when they are used within a 6 month-range between scan date and surgery date.In order to use scans older than 6 months, a surgeon approval is required.In conclusion, there is a significant probability that the duration of time waiting for the prophecy guides mentioned in the incident information did not impact the fit between guides and bone surface.It was not possible to identify what caused the prophecy guides 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.An improvement in the communication to the field was implemented clarifying that the surgery date of the subsequent case created under invision technology will be the same to the initial case created under a different technology.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 more information is provided, the case will be re-assessed.

• Brand Name: PROPHECY INVISION 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: 20153764
• Report Number: 3010667733-2024-00565
• Device Sequence Number: 8369473
• Product Code: HSN
• UDI-Device Identifier: 00840420194725
• UDI-Public: (01)00840420194725(11)240628(17)241228(10)1792534
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2024
• Device Catalogue Number: PROPINV
• Device Lot Number: 1792534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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: Unknown