MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BOOST RESTERILIZABLE GEL SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number	RSZHPB685S
Medical Device Problem Codes	Material Disintegration (1177); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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 a non-conformance was identified related to device malfunction.This non-conformance will be addressed through mentor¿s quality system.Fda correction/ removal reporting no.: (b)(4).Reason for device explant and/or reoperation: no.Information regarding explantation or an expected explantation date has been received.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that two mentor memorygel boost resterilizable gel sizers being used in a breast augmentation were found to be ruptured during the operation.The devices did come into contact with the patient; however, there were no reported patient consequences or procedural delays.This report is for the first of two devices.
Additional Manufacturer Narrative
Manufacturer¿s reference number: (b)(4).After secondary review on jun 13 2022, h6.Medical device problem code a0408 has been added to more accurately capture the event.This issue occurred before the procedure.As a non-implantable device, the potential that this could cause or contribute to a death or serious injury, or other significant adverse event, is remote.As a result, this event has been deemed not reportable and no further investigation will take place.
Additional Manufacturer Narrative
A photo of the device was returned for evaluation.Photo evaluation summary: upon visual evaluation of the images provided in the complaint, both devices were observed ruptured, however, the consistency of the gel could not be evaluated.As the products involved in this complaint were not received, the devices couldn´t be analyzed according to our procedures.Based on the information currently available, a product issue was identified during the investigation of the photos received.This product issue will be addressed through mentor¿s quality system.According to the manufacturing investigation, with consideration of process controls and material specifications, the defects reported cannot be confirmed a manufacturing defect.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BOOST RESTERILIZABLE GEL SIZER
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14655335
• Report Number: 1645337-2022-06826
• Device Sequence Number: 5757014
• Product Code: MRD
• UDI-Device Identifier: 00081317027515
• UDI-Public: 00081317027515
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062421
• 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,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 Model Number: RSZHPB685S
• Device Catalogue Number: RSZHPB685S
• Device Lot Number: 9721346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 06/13/2022; 08/08/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/07/2022; 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown