MAUDE Adverse Event Report: ARTHREX, INC. TBG ADPTR,'Y' DBL SPKD (10-BX); ARTHROSCOPE AND ACCESSORIES

Model Number	TBG ADPTR,'Y' DBL SPKD (10-BX)
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, an fda medwatch notification was received via email.A facility representative reported that an arthrex pump over pressured.After about an hour and a half of being used, the pump had a sudden increase in pressure, it went to 1500 ml/min.The surgeon was notified of the increase in pressure and dimmed it okay to proceed with the surgery.The case was completed with no other changed to the arthrex pump.This was discovered during a procedure on (b)(6) 2024.Additional information received on 11/25/2024: the part number for the pump is unknown.This was discovered during a right aclr procedure.The pump was used with the ar-6215 y-tubing adapter double spike.The pump was set at 35ml/min then increased to 50ml/min.The setting had a sudden change to 1500ml/min.There were not alarms or error messages present prior to or during the event.The surgery was aborted.
Additional Manufacturer Narrative
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 is user error due to disconnecting/reconnecting tubing which may result in pump pressure errors.

• Brand Name: TBG ADPTR,'Y' DBL SPKD (10-BX)
• 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: 20929651
• Report Number: 1220246-2024-08853
• Device Sequence Number: 17466340
• Product Code: HRX
• UDI-Device Identifier: 00888867039025
• UDI-Public: (01)00888867039025(11)240501(17)290430(10)75481531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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 Model Number: TBG ADPTR,'Y' DBL SPKD (10-BX)
• Device Catalogue Number: AR-6215
• Device Lot Number: 75481531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown