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	Extravasation (1842)
Date of Event	06/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One unpackaged ar-6215 y tubing adapter was received attached to an ar-6410 main pump tubing and returned for evaluation.Visual evaluation noted that the ar-6410 main pump tubing had an ar-6215 y tubing adapter attached to the end of one of the double spiked extensions and the returned devices showed signs of use.Functional testing was performed with a known good ar-6480 dualwave pump and water to see if the reported failure could be reproduced.To replicate the conditions in which the reported failure occurred, the pump was set to the knee setting and powered on.The ar-6215 y tubing adapter & ar-6410 main pump tubing were observed to function as intended with no issues noted.Further functional testing was performed where the pump was once again set to the knee setting and run for 30 minutes.During this time, the ar-6410 main pump tubing & the ar-6215 y tubing adapter were observed to function as intended with no changes in pressure noted.Additional functional testing was performed by clamping the end of the ar-6410 main pump tubing to create a closed system.The pump was run for 30 minutes and no problems were noted during this time.No problem found.Refer to investigation photos.Complaint allegation is not confirmed.
Event or Problem Description
On 07/10/2024, it was reported by a sales representative via (b)(4) that an ar-6480 pump is noisy and rotating at a high speed.This occurred during use in a case the patient suffered an extravasation event due to the overpressure.The customer aborted the case immediately.They were able to rectify the issue with the patient, and the patient is reported to be fine.Outcome: as a result of the malfunction, the patient's leg became filled with fluid because the device did not detect the pressure point and continued operating at a high speed.Procedure was an arthroscopic btb acl repair.It was aborted before any major portion of the case could be performed.Per the rn in the room the pump was set to the knee setting which is 35.Yes, extravasation did occur but the fluid was not removed.It reabsorbed.The patient was admitted overnight for observation and was discharged the next day with no signs of compartment syndrome.Recovery has been uneventful.

• 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: 20135028
• Report Number: 1220246-2024-07348
• Device Sequence Number: 7278142
• Product Code: HRX
• UDI-Device Identifier: 00888867039025
• UDI-Public: 00888867039025
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: TBG ADPTR,'Y' DBL SPKD (10-BX)
• Device Catalogue Number: AR-6215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown