MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 50°; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	APOLLO RF 50°
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
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 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 sems that an ar-9815 apollorf¿ mp50, aspirating ablator, 50°, multi-port had an issue, the distal tip broke and fell of rf.This was discovered during use with no impact to the patient.Additional information has been requested.On 09/09/2022, the sales representative replied via email and stated the following information: this event occurred during an acl revision procedure on (b)(6) 2022.The device was inserted into the joint, they started ablation of a couple of intervals of a few seconds each with pauses in between until noticing the white ring had fallen off.The instrument broke inside the patient and all fragments were removed.The device was discarded by the facility.There were no alarm messages, and the ablator did not come in contact with any other devices during use.The case was completed as scheduled.The patient is fine to date.On 9/23/2022, the sales representative called and stated the following information via phone: an x-ray of the patient was taken after the original surgery, and the surgeon deemed a revision surgery necessary to remove the hardware from the patient.The revision surgery took place on (b)(6) 2022, was performed by the same surgeon who initially performed the surgery, and the fragment was fully removed from the patient, verified by another x-ray taken during the surgery.The patient is fine to date, a picture of the removed fragment will be sent via email.

• Brand Name: APOLLO RF 50°
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 15484205
• Report Number: 1220246-2022-05532
• Device Sequence Number: 7831499
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: 00888867142527
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K161581
• 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
• Report Date (Section B): 09/26/2022

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: 05/31/2026
• Device Model Number: APOLLO RF 50°
• Device Catalogue Number: AR-9815
• Device Lot Number: 2101015
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/26/2022
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown