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

Model Number	DOUBLECUT, 4.0MM X 13CM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2019
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 at the beginning of a shoulder scope procedure as the surgeon placed the ar-8400dc, doublecut into the joint and started oscillating, metal flakes started flowing into the joint space.The rep reported it appeared as though metal flakes were already sitting in the chamber of the shaver.The surgeon attempted to suction out all of the metal debris.The rep stated they cannot confirm if all metal flakes were fully suctioned out as there were many of them and the flakes were very small (approximately a millimeter or less).The device will not be returning for evaluation as it was discarded by the facility.Additional information received on 2/19/2019: the rep reported that the case was completed by suctioning out as many flakes as possible, and a second ar-8400dc from the same lot was opened and used to complete the procedure without further issue.

• Brand Name: DOUBLECUT, 4.0MM X 13CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8390785
• Report Number: 1220246-2019-00941
• Device Sequence Number: 19200351
• Product Code: GFA
• UDI-Device Identifier: 00888867043565
• UDI-Public: 00888867043565
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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 Expiration Date: 09/30/2023
• Device Model Number: DOUBLECUT, 4.0MM X 13CM
• Device Catalogue Number: AR-8400DC
• Device Lot Number: 10246137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/05/2019
• 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