MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3501480
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
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.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported to mentor that the mentor smooth round spectrum 475cc was not working properly.The surgeon was placing patients tissue expander when he observed that the port was not working.He used a different port and was able to use the tissue expander.There was no procedure delay and no patient consequence and no adverse event.
Additional Manufacturer Narrative
On (b)(6) 2021 , only the injection reservoir was returned to mentor for evaluation.Mentor then conducted a visual inspection and leak testing of the sample.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the injection reservoir.Leak testing was performed in accordance with mentor's procedures.Findings revealed that the liquid does not flow through the injection reservoir.During the additional investigation performed, it was identified that the tube in the dome was occluded by silicone adhesive.Silicone adhesive is applied during the manufacturing process to adhere the tube to the dome.The investigation identified the root cause as too much adhesive being applied during the manufacturing operations.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue has been addressed through the quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 08/06/2021, 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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 12100569
• Report Number: 1645337-2021-07433
• Device Sequence Number: 19883564
• Product Code: FWM
• UDI-Device Identifier: 00081317002024
• UDI-Public: 00081317002024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2021

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: 03/19/2024
• Device Model Number: 3501480
• Device Catalogue Number: 3501480
• Device Lot Number: 9447356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/06/2021; 08/26/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/26/2021; 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1