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 12/07/2018

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 cuff repair surgery the overheating of the cutter caused a patient burn.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

Complaint confirmed, the shrink tubing was found to be damaged by heat.This event can most likely be observed/replicated when the end user does not have continuous fluid or has low fluid flowing through the device during use.However, the exact root cause of this event cannot be determined at this time.

Manufacturer Narrative

Complaint confirmed, the shrink tubing was found to be damaged by heat.The cause is attributed to a supplier process and two root causes were identified: 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: 8185053
• MDR Text Key: 131041234
• Report Number: 1220246-2018-00818
• Device Sequence Number: 1
• Product Code: GFF
• UDI-Device Identifier: 00888867044050
• UDI-Public: 00888867044050
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• 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: 03/15/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 12/07/2018; 12/07/2018
• Supplement Dates FDA Received: 04/05/2019; 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other