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

Model Number	BLURR, 5.0MM X 13CM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported, that during a shoulder arthroscopic procedure, when the surgeon was burring the accromium, the burr ar-8500bl, inner blade snapped in half, at the base of the shaver.The broken fragment was isolated to the shaver and the case was complete by using another ar-8500bl without further issue.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8500bl blurr was received for investigation.Visual inspection identified that the inner rod had broken proximal to the inner hub component.It was determined that approximately 5.6" of the inner rod had broken off.The connection point between the outer tube and the outer hub was noticeably bent.Material analysis indicated that the inner rod met all as-received specifications.As such, the observed condition is consistent with user applied mechanical forces, such as through prying/leveraging against bone/hard tissue.

• Brand Name: BLURR, 5.0MM X 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11302264
• Report Number: 1220246-2021-02567
• Device Sequence Number: 5036618
• Product Code: GFF
• UDI-Device Identifier: 00888867043749
• UDI-Public: 00888867043749
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: BLURR, 5.0MM X 13CM
• Device Catalogue Number: AR-8500BL
• Device Lot Number: 12300988
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other