MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS LLC MICROAIRE K-WIRE; PIN, FIXATION, SMOOTH

Device Problem Expiration Date Error (2528)

Patient Problem No Information (3190)

Event Date 01/07/2019

Event Type  No Answer Provided  

Event Description

Three expired k-wires were used in an internal fixation of a fracture.The surgeon was informed of the implant expiration date after fixation was complete.Complexity of fixation made immediate removal a greater risk than leaving the wires in for the four week healing period.Patient will return in 4 weeks for removal.Follow-up with infection control for monitoring completed.

• Brand Name: MICROAIRE K-WIRE
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS LLC; charlottesville VA 22911
• MDR Report Key: 8315330
• MDR Text Key: 136240365
• Report Number: MW5083799
• Device Sequence Number: 3
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 02/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 YR