MAUDE Adverse Event Report: ARTHREX, INC. TUBE SET, INFLOW, ARTHROSCOPY; ARTHROSCOPE AND ACCESSORIES

Model Number	TUBE SET, INFLOW, ARTHROSCOPY
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 4/26/2024, it was reported by a sales representative via (b)(4) and (b)(4) that an ar-6485 synergy cw4 arthroscopy pump was incorrectly reading the pressure and causing too much fluid to be pumped.This caused the patient's leg to swell very fast.And the ar-6413 tube set was then "ruined" after the event.The procedure had to be stopped to get the swelling under control.This was discovered during a procedure.
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.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, g3, h1, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error.It was reported that the neoprene of the ar-6413 tubing was flattened/compressed, the most common causes for this occurrence are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.Per dfu-0140-eo revision 0, h.Directions for use: warning: using fluid to distend any joint carries with it the possibility of fluid extravasation into surrounding tissue.Always use the lowest possible pressure settings to achieve the desired amount of distension and control of bleeding.Warning: proper operation of this device requires the establishment of adequate fluid outflow and monitoring of the surgical field.At pressures exceeding 10 mmhg above the patient¿s diastolic pressure, carefully monitor and maintain fluid outflow and assess the patient regularly to avoid extravasation or any other adverse patient condition.Warning: do not disconnect and reconnect the same tubing set under any circumstances.Once disconnected from the pump, the tubing set must be discarded and a new tubing set installed.Failure to do so may result in pump failure and patient injury.Failure to follow these instructions may pose a danger to the patient.Do not use the unit if the rollers turn continuously after the tubing has been clamped.
Event or Problem Description
Additional information was received on 5/1/2024: it was reported by the sales representative that the neoprene sleeve had flattened and/or compressed.Additional information was received on 5/3/2024: this was discovered during a knee arthroscopy with removal of loose body and a tibial tubercle osteotomy on (b)(6) 2024.Due to the malfunction, they decided not to do the osteotomy after this problem occurred, and therefore, the procedure was only a knee-scope procedure.The excess fluid was located on the right leg.The procedure to remove the excess fluid occurred during the initial surgery and was done by the surgeon by pushing on and squeezing the leg to remove the fluid manually.No case delay was reported, or additional anesthesia was needed, and the patient was discharged the same day.

• Brand Name: TUBE SET, INFLOW, ARTHROSCOPY
• Common Device Name: ARTHROSCOPE AND 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: jared engle ; 8009337001
• MDR Report Key: 19394889
• Report Number: 1220246-2024-03889
• Device Sequence Number: 15389540
• Product Code: HRX
• UDI-Device Identifier: 10888867311326
• UDI-Public: 10888867311326
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TUBE SET, INFLOW, ARTHROSCOPY
• Device Catalogue Number: AR-6413
• Device Lot Number: 73591219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown