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

Device Problems Overheating of Device (1437); Excessive Heating (4030)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Date 10/29/2018

Event Type  Injury  

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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 128725832
• Report Number: 1220246-2018-00770
• Device Sequence Number: 1
• Product Code: GFF
• UDI-Device Identifier: 00888867044050
• UDI-Public: 00888867044050
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 11/08/2018; 11/08/2018; 11/08/2018
• Supplement Dates FDA Received: 12/11/2018; 06/07/2023; 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other