MAUDE Adverse Event Report:; PLATE, FIXATION, BONE

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/30/2021

Event Type  malfunction  

Event Description

Distal tip of a k-wire broke off and was buried deep inside the bone.Due to risk involved in removing k-wires, surgeon made the decision to leave k-wire in.

• Type of Device: PLATE, FIXATION, BONE
• MDR Report Key: 11874780
• MDR Text Key: 252350481
• Report Number: 11874780
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13505 DA