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

Model Number PROPINB

Device Problem Inaccurate Information (4051)

Patient Problem Insufficient Information (4580)

Event Date 06/21/2022

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 296146513
• Report Number: 3010667733-2022-00249
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797057110
• UDI-Public: 00889797057110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1