MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL XTRA BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	TMPX240
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 240cc textured mentor memorygel xtra breast implant being used for a primary breast augmentation was found to be ruptured intraoperatively.The surgeon discovered the rupture during surgery.As a result, the ruptured implant was replaced with like device, catalog # tmpx240, serial # (b)(4) on (b)(6) 2020.There were no reported patient consequences or surgical delays.
Additional Manufacturer Narrative
The mentor failure analysis lab has completed the evaluation of the suspect medical device.Device evaluation summary: during visual evaluation a tear was observed on the anterior view, measuring approximately 5.5 cm.Additionally, an area of missing material within the tear was noted, measuring approximately 0.5 cm x 0.3 cm.Microscopic examination of the edges of the tear and missing material revealed parallel striations that are consistent with markings made by a sharp instrument perforating silicone material.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information is consistently analyzed and monitored by quality assurance to determine when further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 23-apr-2020, a manufacturing record evaluation (mre) was completed, 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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9869705
• Report Number: 1645337-2020-04725
• Device Sequence Number: 11523218
• Product Code: FTR
• UDI-Device Identifier: 00081317025436
• UDI-Public: 00081317025436
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2020

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: 04/12/2023
• Device Model Number: TMPX240
• Device Catalogue Number: TMPX240
• Device Lot Number: 7568879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 10/20/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/29/2020; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1