MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS LLC MICROAIRE KIRSCHNER WIRES MICROAIRE STEINMANN PINS; PIN, FIXATION, SMOOTH

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2017

Event Type  Injury  

Event Description

Patient admitted with grade 1 open fracture of the hand.During surgery, k-wire failure upon insertion and breakage within the bone of the proximal phalanx.Surgeon made attempts to remove fractured kwire.Surgeon that risks outweighed the benefits and left the retained wire in bone.

• Brand Name: MICROAIRE KIRSCHNER WIRES MICROAIRE STEINMANN PINS
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS LLC; 3590 grand forks blvd.; charlottesville VA 22911
• MDR Report Key: 6379823
• MDR Text Key: 69106475
• Report Number: 6379823
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/15/2017,02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• 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: 02/15/2017
• Event Location: Other
• Date Report to Manufacturer: 02/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR