MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA SS, T EXP, HP,750CC; EXPANDER, SKIN, INFLATABLE

Model Number	SMXP150RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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.Reason for device explant and/or reoperation: na.(b)(4).
Event or Problem Description
It was reported that a mentor artoura breast tissue expander, 750cc, saline implant deflated before the surgery.The reporter indicated that this expander was never in contact with the patient.A separate sterile field is set up for the plastic surgeon.The plastic surgeon does a test fill prior to inserting the expander.At that time, he noted there to be leaking from the expander.He had not placed it in or on the patient, at any time.He had not touched the patient yet at this time.
Additional Manufacturer Narrative
Device evaluation completed on (b)(6) 2020: during the visual evaluation of the device, no apparent damage was observed.Leak testing was performed in accordance with mentor's procedures.Two (2) tears were observed on the anterior view, both measuring less than 0.1 cm.Microscopic examination on both tear edges revealed parallel striations that are consistent with markings made by a sharp instrument perforating silicone material.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number (b)(4).

• Brand Name: ARTOURA SS, T EXP, HP,750CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10987670
• Report Number: 1645337-2020-15760
• Device Sequence Number: 629264
• Product Code: LCJ
• UDI-Device Identifier: 00081317024347
• UDI-Public: 00081317024347
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 03/17/2023
• Device Model Number: SMXP150RH
• Device Catalogue Number: SMXP150RH
• Device Lot Number: 7697751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1