MAUDE Adverse Event Report: MICROAIRE K-WIRE GUIDE PIN

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2017

Event Type  malfunction  

Event Description

Patient undergoing bankhardt repair, k-wire guide pin broke.

• Brand Name: K-WIRE GUIDE PIN
• Type of Device: K-WIRE
• Manufacturer (Section D): MICROAIRE; 3590 grand forks blvd.; charlottesville VA 22911
• MDR Report Key: 6273682
• MDR Text Key: 65773248
• Report Number: MW5067401
• Device Sequence Number: 1
• Product Code: HTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR