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

Model Number	THPX325
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon visual evaluation of the image provided in the complaint, the implant was observed ruptured with its gel exposed.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation was performed for the finished device batch number (b)(4) and no non-conformances were identified.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 325cc mentor memorygel xtra breast implant ruptured intraoperatively.There were no noted patient consequences.
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on (b)(6) 2021.The analysis has begun but is not complete at this time.When the investigation and analysis have been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on (b)(6) 2021.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the breast implant had an area of siltex cracking on the anterior view.Additionally, a tear was found within the siltex cracking measuring approximately 2.5 cm.It should be noted that product failure is multifactorial.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: it is possible to damage the implant during insertion.Ensure that excessive force is not applied to a very small area of the shell during insertion of the device through the incision.Instead, apply force over as large an area of the implant as possible.Avoid pushing the device into place with one or two fingers in a localized area, as this may create an area of weakness on the shell.In addition, an incision should be of appropriate length to accommodate the style, size, and profile of the implant.This will reduce the potential for creating excessive stress to the implant during insertion and will avoid the risk of damage to the implant.Siltex cracking is ultimately a result of high stresses.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 WORLDWIDE LLC; 33 technology drive; irvine 92618
• MDR Report Key: 11821462
• Report Number: 3006942524-2021-00010
• Device Sequence Number: 19781307
• Product Code: FTR
• UDI-Device Identifier: 00081317025672
• UDI-Public: 00081317025672
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• 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: 01/31/2023
• Device Model Number: THPX325
• Device Catalogue Number: THPX325
• Device Lot Number: 7541911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/21/2021; 06/16/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/11/2021; 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1