MAUDE Adverse Event Report: SYNTHES USA 1.6MM KIRSCHNER WIRE WITH 5MM THREAD- TROCAR POINT 150MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 292.71

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

Kwire broke off inside patient's right tibia during open reduction and internal fixation (orif) of right tibia plateau fracture.Unable to retrieve broken kwire piece.

• Brand Name: 1.6MM KIRSCHNER WIRE WITH 5MM THREAD- TROCAR POINT 150MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 14944531
• MDR Text Key: 295415448
• Report Number: 14944531
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2022,06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 292.71
• Device Catalogue Number: 29271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2022
• Date Report to Manufacturer: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White