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

Model Number	EXCALIBUR, CURVED 4.0MM X 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported during a knee scope the shaver burr broke.It was replaced and the same event occurred.It was replaced a third time and the case was completed with no further issues.Everything was retrieved and the patient is fine to date.The caller had no further details.
Additional Manufacturer Narrative
Complaint was not confirmed.The device was returned disassembled.Visual evaluation did not showed any breakage to the returned device.No problem found.

• Brand Name: EXCALIBUR, CURVED 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: 11947449
• Report Number: 1220246-2021-03219
• Device Sequence Number: 14261710
• Product Code: GFA
• UDI-Device Identifier: 00888867043503
• UDI-Public: 00888867043503
• 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: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: EXCALIBUR, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CEX
• Device Lot Number: 12451590
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1