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

Model Number	PROPINB
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the label on the alignment guide did not match the patient case number.The guide was labeled for another case.
Additional Manufacturer Narrative
Corrections: d9/h9, h3.The reported event could be confirmed, since intraoperative images provided do show the wrong case number on the tibial guide.Information provided by the rep indicates the surgeries were performed 3 weeks apart, which indicates mix-up at the hospital is unlikely.Based on investigation, the root cause was attributed to a product mix-up related issue.The failure was caused by the parts being mixed during production inspection or packaging.It should be noted, all prophecy cases are accompanied by standard surgical instrumentation for use by the surgeon if needed.A nonconformance investigation was initiated to investigate in further detail and determine any additional necessary actions.
Event or Problem Description
It was reported that the label on the alignment guide did not match the patient case number.The guide was labeled for another case.

• Brand Name: PROPHECY INBONE 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: 15042733
• Report Number: 3010667733-2022-00249
• Device Sequence Number: 15185818
• Product Code: HSN
• UDI-Device Identifier: 00889797057110
• UDI-Public: 00889797057110
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110360
• 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): 10/09/2022

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: 10/22/2022
• Device Model Number: PROPINB
• Device Catalogue Number: PROPINB
• Device Lot Number: 1731247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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