MAUDE Adverse Event Report: DUPUY SYNTHES, JOHNSON AND JOHNSON SYNTHES; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Patient Problem Foreign Body In Patient (2687)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

During an orthopedic surgery tibial plateau open reduction internal fixation with ordinary use, a synthes 2.5 mm hexagonal driver 314.550 became sheared off at the tip.The tip could fused to the head of the screw.Tip unable to be retrieved.Attempting to remove would cause more harm so intentionally retained.

• Brand Name: SYNTHES
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): DUPUY SYNTHES, JOHNSON AND JOHNSON
• MDR Report Key: 18588600
• MDR Text Key: 333965256
• Report Number: MW5150753
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White