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

Model Number	PROPINF
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tibial block for this case had a ridge on it that prevented the cut guide from going all the way down.It sat like 5mm higher than it should have.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported that the tibial block for this case had a ridge on it that prevented the cut guide from going all the way down.It sat like 5mm higher than it should have.
Additional Manufacturer Narrative
Correction - h6 (method code).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.An investigation was conducted by the prophecy team and 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.The saw guide is expected to sit off from the anterior surface of the psi guide, 3mm is nominal but can vary because there is manufacturing variability to account for.The sides of the guide and the pocket are tapered very slightly so the parts will wedge together.The parts were requested to the sales rep for further inspection on 08-mar-23.A reply from the sales rep was not received.Root cause: it was not possible to identify a potential root cause to the issue mentioned in the event description.A potential root cause may be a discrepancy in user expectations vs guide fit and feel during surgery or user error during surgery.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: 16660693
• Report Number: 3010667733-2023-00165
• Device Sequence Number: 15263285
• Product Code: HSN
• UDI-Device Identifier: 00889797057134
• UDI-Public: 00889797057134
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: PROPINF
• Device Catalogue Number: PROPINF
• Device Lot Number: 1754876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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
• Patient Sex: Female