MAUDE Adverse Event Report: NOVO SURGICAL, INC. KIRSCHNER TRACTION BOW; COMPONENT, TRACTION, NON-INVASIVE

Device Problem Electromagnetic Interference (1194)

Patient Problem Pain (1994)

Event Date 11/07/2019

Event Type  Injury  

Event Description

Patient went into 1.5 mri unit with kirschner bow used for skeleton traction.It is a newer product being used within the hospital, the techs on the evening of the event did not check, they thought it was just another fixator.When the patient got close to the magnet, the patient starts to complain of pain, patient was removed from magnet.This is when the techs discovered it was ferrous.The patient was sent back to his room, had the traction device removed and rescanned without incident.No further pain or harm to patient.Fda safety report id # (b)(4).

• Brand Name: KIRSCHNER TRACTION BOW
• Type of Device: COMPONENT, TRACTION, NON-INVASIVE
• Manufacturer (Section D): NOVO SURGICAL, INC.
• MDR Report Key: 9321961
• MDR Text Key: 166737458
• Report Number: MW5091077
• Device Sequence Number: 1
• Product Code: KQZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 21 YR
• Patient Weight: 84