MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, 4.0MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	EXCALIBUR, 4.0MM X 13CM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
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 device was reported to have been discarded.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 a 4.0mm oval burr, ar-8400obe, and a 4.0mm excalibur, ar-8400ex, were being used during a shoulder arthroscopy procedure.During use, either the 4.0 excalibur or 4.0 oval burr left flakes in the joint.The rep was unable to determine which device the flakes came from.Additional information provided (b)(6) 2019: the flakes appeared during sad.The patient had normal quality tissue.The flakes were not able to be fully removed from the joint.Dualwave outflow tubing was not used in the case and there was an uninterrupted flow of irrigation through the device during its use.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed the presence of horizontal grooves inferior to the cutting window of the ar-8400ex inner tube.Corresponding grooves were identified within the inner diameter of the outer tube window, and consistent with a site of metal debris production.Material analysis confirmed the ar-8400ex met all as-received specifications.This event is consistent with user applied mechanical force via prying/leveraging, as further evidenced by the presence of scuffing along the shrink tubing at the proximal end of the device.

• Brand Name: EXCALIBUR, 4.0MM 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: 8961070
• Report Number: 1220246-2019-01292
• Device Sequence Number: 3146931
• Product Code: GFF
• UDI-Device Identifier: 00888867043589
• UDI-Public: 00888867043589
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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
• Operator of Device: Health Professional
• Device Model Number: EXCALIBUR, 4.0MM X 13CM
• Device Catalogue Number: AR-8400EX
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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