MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 90° MULTIPORT; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF 90° MULTIPORT
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 6/11/2024, it was reported by an arthrex employee via sems-(b)(4) that an ar-9811 apollorf mp90 tip of the electrode was chipped during use.The case was completed with another ar-9811 apollorf mp90.This was discovered during use on (b)(6) 2024, with no reported patient harm.Additional information was received on 6/13/2024: this was discovered during a arcr procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9811 apollo lot number: 68441349 was received for investigation.Visual evaluation noted that the tip of the device was damaged, the ceramic face was broken and the electrode had signs of wear and use.Slight scorch marks were further noted on the tip of the device.Functional testing was unable to be performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse due to user error caused by prying/leveraging of the device against bone/bony tissue.The most likely cause for the observed scorch marks can be attributed to misuse due to the use of the device for extended periods, and/or excessive activation time of the device causing it to overheat.Per dfu-0242-7 at revision 0.E.Precautions.5.Do not use excessive force when inserting or removing the rf probe.Do not insert the rf probe into an obstructed passageway.Patient injury and or product damage may occur.6.Do not use an rf probe as a lever to enlarge the surgical site or gain access to tissue, which may result in a bent or damaged rf probe.7.Always keep the tip of the active rf probe completely immersed in conductive irrigation fluid (saline, ringers¿ lactate, etc.), regardless of the type of arthroscopic surgery being performed.Do not use pre-warmed conductive irrigation fluids as this may result in tissue damage or thermal injury.8.A continuous flow of irrigation fluid is necessary during use of the apollo probes.Fluid flow assists in removing tissue debris and reducing the intra-joint temperature between activations.Rf probes utilized in stagnant fluid can result in heated irrigant in the joint, which can result in tissue damage inside the joint, skin burns near portals or result in damage to the probe.13.Prolonged ablation should be avoided.Intermittent pauses in ablation are recommended, to allow warm fluid and tissue debris to be evacuated from the joint.Prolonged probe activation while using the suction feature may result in elevated shaft or suction tubing temperatures.

• Brand Name: APOLLO RF 90° MULTIPORT
• 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: 19681226
• Report Number: 1220246-2024-06601
• Device Sequence Number: 3115923
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: 00888867248243
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: APOLLO RF 90° MULTIPORT
• Device Catalogue Number: AR-9811
• Device Lot Number: 68441349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown