MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 12 FLUTE 5.5MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BURR, OVAL, 12 FLUTE 5.5MM X 13CM
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed heat damage across od (outer diameter) of the ar-8550obt outer tube.The 304l stainless steel was observed to have a 42.67mm patch of discoloration indicative of high heat exposure along the od of the device.This event is most likely observed when the end user does not have fluid or has low fluid flowing through the device during use.
Event or Problem Description
It was reported that during a case, the surgeon was using an oval burr, ar-8550obt.While in use, the made weak sounds right from the beginning, got very hot and left a small burn mark on the patient near the portal.Additional information provided 12/4/2016: this occurred during a shoulder arthroscopy procedure.The device was only in use for 15 seconds.No photos were taken.
Additional Manufacturer Narrative
Additional info: complaint confirmed.Visual evaluation revealed heat damage across the od of the ar-8550obt outer tube.The 304l stainless steel was observed to have a 42.67mm patch of discoloration indicative of high heat exposure along the od of the device.The cause is attributed to a supplier process, and two root causes were identified: material and measurement.Material: material is considered to be a root cause as components that did not meet specification contributed to the event.Because the heat shrink recovered outer diameter and the outer tube inner diameter were oversized and undersized respectively, proper clearance did not exist between the burr components which cause the generation of heat.Measurement: measurement is considered to be a root cause due to the inadequate ""spins freely"" test which allowed nonconforming material to be accepted into inventory.
Event or Problem Description
Additional information provided 12/27/2018: the pump used was an arthrex dualwave pump using inflow/outflow.Inflow pressure was 60, outflow cannula suction was medium, shaver suction was high.The surgeon uses the pump outflow with the cannula tubing connected to an outflow cannula, and the shaver tubing attached to the shaver.He uses suction from our outflow pump, which is hooked up to a separate manifold on the neptune, set on low suction.This occurred during a rotator cuff procedure.Surgeon literally put it in the shoulder for 10 seconds, it started making a weird sound, then stopped completely.Rep grabbed another burr, and as he was doing that, he noticed a burn mark on the shoulder where the burr was.Then as the tech was removing the burr from the handpiece, she said, "wow, this is so hot!".The rep put in the new burr and everything worked perfect for the rest of the case.

• Brand Name: BURR, OVAL, 12 FLUTE 5.5MM X 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 8174729
• Report Number: 1220246-2018-00807
• Device Sequence Number: 2025556
• Product Code: GFF
• UDI-Device Identifier: 00888867044050
• UDI-Public: 00888867044050
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: BURR, OVAL, 12 FLUTE 5.5MM X 13CM
• Device Catalogue Number: AR-8550OBT
• Device Lot Number: 10211276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown