MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS, LLC 1000ET ELECTRIC MOTOR MODULE

Model Number 1000ET

Device Problem Overheating of Device (1437)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

Multiple attempts have been made to request that the end-user send any devices or accessories associated with this event to microaire surgical instruments for evaluation.At the time of this report, the device(s) have not been made available.If device(s) are made available, this report will be updated with the results of the evaluation.A review of the device history record associated with part# 1000et/serial# (b)(4) did not reveal any anomalies that would result in the reported event.It was revealed that the device was manufactured on 7/14/2010 and has never been sent to microaire surgical instruments for service/repair.The customer was notified that, per instructions for use, it is recommended that this device be returned for routine inspection and service at least once a year.A review of the complaint history associated with this device has revealed that it is performing as expected, with regard to the reported failure mode.As the device was not returned, the cause exact cause cannot be determined; however, the failure was likely caused by wear to the device due to failure to perform adequate maintenance.

Event Description

Microaire surgical instruments was notified via mw5089458 that during a left total hip arthroplasty, a part# 1000et, electric motor module, with a burr attachment was placed on the drape over the patient's left flank for an unknown period of time between uses.The device overheated, causing a burn to the patient's left flank.At the conclusion of surgery, it was noted that the patient had sustained a full thickness burn to the left flank and bacitracin ointment and a dressing were applied.The patient was later seen as an outpatient for a partial excision of the burned area.

Manufacturer Narrative

During a review of files it was revealed that a supplemental submission was required for mdr# 2020601-2019-00011.

• Brand Name: 1000ET ELECTRIC MOTOR MODULE
• Type of Device: 1000ET ELECTRIC MOTOR MODULE
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville VA 22902
• MDR Report Key: 9182506
• MDR Text Key: 162859662
• Report Number: 2020601-2019-00011
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1000ET
• Device Catalogue Number: 1000ET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other