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

Model Number	EXCALIBUR, 4.0MM X 13CM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/17/2019
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported during a knee arthroscopy with menisectomy procedure the surgeon noticed metal shavings floating in the joint space while using the ar-8400ex, excalibur.The issue occurred as the surgeon was shaving the meniscus.The shavings were sucked out with the shaver and the case was completed.The rep stated a second device was not needed, and there was no harm or injury to the patient.The bone quality was medium.Dualwave outflow was not being used.The rep stated there was not an arthrex rep present during the procedure, and the surgeon informed them of the issue post-op.The rep reported the issue has been occurring across different lots and part numbers but the issue has been primarily with ar-8400ex, (lot: 10324466).Additional information received on 10/02/2019: the rep reported the surgeon did their best to remove all the shavings, but it cannot be confirmed that all shavings were fully removed.The complaint device is available to return for evaluation.The rep stated there is no available information with regard to other arthrex devices malfunctioning as arthrex representatives were not present.

• Brand Name: EXCALIBUR, 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: 9219983
• Report Number: 1220246-2019-01367
• Device Sequence Number: 2388618
• Product Code: GFA
• UDI-Device Identifier: 00888867043589
• UDI-Public: 00888867043589
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

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: 05/31/2024
• Device Model Number: EXCALIBUR, 4.0MM X 13CM
• Device Catalogue Number: AR-8400EX
• Device Lot Number: 10324466
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/22/2019
• 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