MAUDE Adverse Event Report: TENEX HEALTH, INC. TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	554-3003-001
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Interviews were conducted with the physician user, another medical advisor to tenex health, the sales distributor and other personnel at the facility.Pictures of the device were provided, although the device was discarded by the facility.It was determined that various technique steps and alerts were not properly followed.The user apparently continued using the device after aspiration was compromised and the occlusion alerts were triggered.The user also appears to have been "coring" the bone with a more forceful or deeper application than instructed and to not have been following the instructed duty cycle during operation.These three factors are believed to have caused the device overheating that led to the superficial skin burn.
Event or Problem Description
A patient developed a superficial skin burn following a knee procedure with the tx system and a txb microtip.The treating physician experienced excessive occlusions of the aspiration during the case an observed the handpiece to be overheating.The procedure was interrupted by the event.A dressing was applied to the burn site, and it apparently healed normally.No complications from the burn were noted at patient follow-up 1 week after the procedure.The patient still required final treatment for the initial presenting condition, however, due to the procedure interruption.

• Brand Name: TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• MDR Report Key: 11532560
• Report Number: 1000135560-2021-00022
• Device Sequence Number: 5257775
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: 00857156006093
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K181367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2021

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: 554-3003-001
• Device Catalogue Number: 554-3003-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 17 YR
• Patient Weight: 142