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	10/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed heat damage across the outer diameter of the ar-8550obt outer tube.The 304l stainless steel was observed to have patches of discoloration indicative of high heat exposure along the outer diameter 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 rotator cuff repair, they were using the burr to resection 5mm of distal clavicle.They were hearing a high pitched noise, which they thought was from the shaver so they replaced the shaver.They reconnected the burr to another shaver.The noise continued and the shaft of the burr got too hot to touch and the patient got burned at the posterior portal.They used silver compound on the wound.There were no additional incisions or hospitalization required and the case was completed.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed heat damage across the od (outer diameter) of the ar-8550obt outer tube.The 304l stainless steel was observed to have patches 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.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed heat damage across the od of the ar-8550obt outer tube.The 304l stainless steel was observed to have patches 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.

• 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: 8114738
• Report Number: 1220246-2018-00770
• Device Sequence Number: 16724927
• Product Code: GFF
• UDI-Device Identifier: 00888867044050
• UDI-Public: 00888867044050
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup,Followup
• Report Date (Section B): 06/08/2023

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: 11/19/2018
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018; 11/08/2018; 11/08/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/11/2018; 06/07/2023; 06/08/2023
• 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