MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, 5.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	EXCALIBUR, 5.0MM X 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2021
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
The following was found during a maude review: it was reported that during a right acl reconstruction arthroscopy procedure, when the surgeon was using a 5.0mm arthrex shaver, ar-8500ex, lot: 10453589, a section of the shaver's outer sheath broke off and was discovered while surgeon was closing the subcutaneous tissue.The surgeon was able to retrieve the section in its entirety after it was viewed under fluoroscopy.The first layer of subcutaneous tissue had been closed at this point and had to be reopened and the sheath fragment removed.The patient was still under anesthesia at this time.The subcutaneous tissue and skin layers were closed by the surgeon without further incident.

• Brand Name: EXCALIBUR, 5.0MM 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: 12300604
• Report Number: 1220246-2021-03499
• Device Sequence Number: 4382405
• Product Code: GFA
• UDI-Device Identifier: 00888867043817
• UDI-Public: 00888867043817
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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: 10/31/2024
• Device Model Number: EXCALIBUR, 5.0MM X 13CM
• Device Catalogue Number: AR-8500EX
• Device Lot Number: 10453589
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1