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	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device 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 both sets of prophecy guides arrived to the account in pristine condition.After wash and sterilization, there appeared to be spots of discoloration on the guides.Unfortunately, both cases had to be cancelled.Rescheduled date for surgery tbd.
Event or Problem Description
It was reported that both sets of prophecy guides arrived to the account in pristine condition.After wash and sterilization, there appeared to be spots of discoloration on the guides.Unfortunately, both cases had to be cancelled.Rescheduled date for surgery tbd.
Additional Manufacturer Narrative
The reported event (fading color, discoloration, marking) could be confirmed, since imaging obtained during the investigation do show the guides have a yellowish brown discoloration.Information obtained during the investigation determined that the account was drying the guides for 30 minutes instead of the recommended 20 minutes found in the instructions of use and the sterile indicators were placed in direct contact with the guides during sterilization.The facility adjusted these drying parameters to match ifu and wrapped the sterile indicators and the issue could not be recreated.Based on the investigation, the root cause was determined to be a user related issue.The issue was most likely caused by incorrect sterilization processing parameters by the facility.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: 19713241
• Report Number: 3010667733-2024-00428
• Device Sequence Number: 8575941
• Product Code: HSN
• UDI-Device Identifier: 00889797057134
• UDI-Public: (01)00889797057134(11)240424(17)241024(10)1788151
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131283
• 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: 10/24/2024
• Device Catalogue Number: PROPINF
• Device Lot Number: 1788151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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