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	Burn, Thermal (2530)
Date of Event	12/05/2018
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 requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the ar-8400cex, excalibur blade stopped turning/oscillating during debridement at the very end of a knee scope procedure.The facility states that the device overheated, and burned the patient at the portal site.The rep stated there was not a cannula used, and the shaver blade made direct contact with the patient's skin.The rep confirmed that there was not an arthrex sales representative present during the procedure.The rep stated that the case was completed, and a new ar-8400cex was not needed as the surgical step had been completed.The facility informed the rep that there is a follow-up visit scheduled with the patient on (b)(6) 2018 to re-bandage and assess the burn wound.Update (b)(4) 2018: at time of report to the fda further information with regard to the patient follow up visit was requested but has not been received.
Additional Manufacturer Narrative
Complaint was confirmed.Visual examination shows grinding marks on the bone cutter, indicating it is rubbing against the outer tube.Scratches can also be seen on the distal end of the outer tube.Visual examination also revealed that the outer tube assembly is curved toward the distal end.Functional evaluation shows the device is not rotating at all.The most likely cause(s) of this type of event include excessive bending force applied to the device during use.

• 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: 8202824
• Report Number: 1220246-2018-00814
• Device Sequence Number: 19246673
• Product Code: GFA
• UDI-Device Identifier: 00888867043503
• UDI-Public: 00888867043503
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 01/11/2019

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: 07/31/2023
• Device Model Number: EXCALIBUR, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CEX
• Device Lot Number: 10231129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 01/11/2019
• 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