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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
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
On (b)(6) 2022, it was reported by a sales representative via email that an ar-8400cex excalibur broke while preforming a medial meniscectomy.The excalibur broke while inside the sheath and all the broken fragments were accounted for.A new ar-8400cex excalibur was opened and case was completed without further issues.This was discovered during a meniscectomy procedure on (b)(6) 2022.
Additional Manufacturer Narrative
The complaint is confirmed.(1) unpackaged ar-8400cex was received for evaluation.Visual inspection revealed the outer tube is bent below the normal curvature.Rotation of the outer hub did not result in rotation of the tip of the inner tube assembly.A likely point of failure are the 3 coils from the inner tube assembly, located at the curvature of the outer tube.However, without disassembling and potentially damaging the device, this failure cannot be verified.Thus, the cause for the device not rotating as intended remains undetermined.The cause for the bent outer tube can be attributed to misuse, which likely resulted in application of excessive mechanical forces on the outer tube via prying and/or leveraging.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14976665
• Report Number: 1220246-2022-05205
• Device Sequence Number: 20092580
• Product Code: GFA
• UDI-Device Identifier: 00888867043503
• UDI-Public: 00888867043503
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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 Model Number: EXCALIBUR, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CEX
• Device Lot Number: 14919235
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown