MAUDE Adverse Event Report: ARTHREX, INC. APOLLORF¿ XL90, ASPIRATING ABLATOR 90°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/25/2022, it was reported by an arthrex employee via (b)(4) that an ar-9821 apollorf aspirating ablator lining that protects the shaft of the device, is worn.This was discovered during a knee arthroscopy and acl procedure on (b)(6) 2022.The device did not fail during the procedure, however, because of the lining being worn out and the risk of leaving residue inside the patient, another ablator was used to complete the case.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed based on the customer provided photo, which displays the shaft of the ablator peeling.However, without return of the device for physical evaluation, the most likely cause of the reported failure is wear and tear.

• Brand Name: APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
• Common Device Name: ELECTROSURG CUT/COAG DEVICE
• 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: jared engle ; 8009337001
• MDR Report Key: 19470852
• Report Number: 1220246-2024-04974
• Device Sequence Number: 3554472
• Product Code: GEI
• UDI-Device Identifier: 00888867267220
• UDI-Public: 00888867267220
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
• Device Catalogue Number: AR-9821
• Device Lot Number: 2109072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown