MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS XPS BUR; BUR, EAR, NOSE AND THROAT

Model Number 1883672HS

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Burn, Thermal (2530)

Event Date 07/24/2017

Event Type  malfunction  

Event Description

Doctor was using an m5 straight shot drill bit 70° at 30000 rpm during endoscopic surgery.It burned the exterior of the drill bit at the curved area.According to the electronic medical record, the patient suffered an excoriation/thermal injury to the left nostril.It is being treated with topical antibiotic ointment.It is unclear if this was an equipment malfunction.Confirmed with doctor that he was using high-speed bur with m5 handpiece.Follow-up investigation shows this model of bur has a maximum rpm rating of 12,000, but was being used at 30,000.There is no mechanism that prevents the drill from being operated above the maximum rated speed.The only labeling that indicates 12,000 rpm is small and easy to miss.Most of the other burs we stock are rated for 30,000 rpm.Manufacturer response for surgical drill disposable bur, medtronic xomed (per site reporter): pending investigation.

• Brand Name: XPS BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st.; fort worth TX 76137
• MDR Report Key: 6800035
• MDR Text Key: 82895717
• Report Number: 6800035
• Device Sequence Number: 1
• Product Code: EQJ
• 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: Other
• Type of Report: Initial
• Report Date: 08/10/2017,08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Other
• Patient Age: 40 YR