MAUDE Adverse Event Report: MENTOR TEXAS MENTOR TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	3504307M
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 550cc mentor tissue expander had a defective valve that was noted intraoperatively.There was no adverse event or increased risk to the patient.The procedure was continued using a backup device.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on june 9, 2023.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the tissue expander.In addition, the tubing was found separated.Leak testing was performed, in accordance with mentor procedures, and the air passed through the fill tubing, and the tissue expander could be inflated and deflated.In addition, water passed through the injector reservoir valve and the filling tube.A microscopic examination was performed on the edges of the rupture to the fill tubing and revealed parallel striations that are consistent with markings made by a sharp instrument, indicating that the tube was cut.The event described could not be confirmed as the injector reservoir valve was received separately and cut from the returned tissue expander.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on may 10, 2023.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 16702157
• Report Number: 1645337-2023-04103
• Device Sequence Number: 19740217
• Product Code: LCJ
• UDI-Device Identifier: 00081317002437
• UDI-Public: 00081317002437
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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 Expiration Date: 07/27/2025
• Device Model Number: 3504307M
• Device Catalogue Number: 3504307M
• Device Lot Number: 9592784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2023
• Supplement Date Received by Manufacturer: 05/10/2023; 06/09/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/31/2023; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 60 KG