MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 8 FLUTE 5.0MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number BURR, OVAL, 8 FLUTE 5.0MM X 13CM

Device Problems Overheating of Device (1437); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during a procedure, upon utilization of the oval burr, ar-8500obe, after 5-10 minutes of acromioplasty, the burr began heating up, causing cauterization of patient blood to form on the shaft of the burr.No adverse patient consequences and case was completed without further incident.Additional information provided 12/21/2018: this occurred during a sad procedure.Settings of the console were 8000rpm.No outflow tubing was used during this case.Additional information provided 12/21/2018: the rep confirmed that the patient was burned with the burr at the incision site.

Manufacturer Narrative

This follow-up submission is due to an update to the event description as well as for device evaluation.Complaint confirmed.Evaluation reveals friction can be felt when spinning the inner tube.The inner tube does not spin freely.The distal end of the shrink tube on the inner tube appears white and damaged from friction and heat.This event is most likely caused by not having fluid or low fluid flowing through the device during use.

Event Description

Additional information provided 2/14/2019: the surgeon stated that the burr heated and caused a second degree burn 2¿x2¿ at the skin entry site not just coagulation of the blood.Also, suction tubing was in use and functioning the entire time of the burr usage.At the start of the case, the burr ran smoothly but within a few minutes it began to slow and then locked as if something was binding within the shaft of the burr.

• Brand Name: BURR, OVAL, 8 FLUTE 5.0MM 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: 8228497
• MDR Text Key: 132564814
• Report Number: 1220246-2019-00840
• Device Sequence Number: 1
• Product Code: GFF
• UDI-Device Identifier: 00888867043862
• UDI-Public: 00888867043862
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

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: 07/31/2023
• Device Model Number: BURR, OVAL, 8 FLUTE 5.0MM X 13CM
• Device Catalogue Number: AR-8500OBE
• Device Lot Number: 10228122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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