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

Model Number	RSZHPB325S
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mentor failure analysis lab 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: n/a.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a mentor memorygel boost resterilizable gel sizer was identified to have black dots prior to use.No adverse event or patient consequence was reported.
Additional Manufacturer Narrative
On november 30, 2022, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, leak testing of the returned device, and material evaluation.Visual analysis of the returned device determined that particles were found embedded in the gel.The size of particle a was 0.0005 cm² (0.05 mm²), the size of particle b was 0.0005 cm² (0.05 mm²), and the size of particle c was 0.003 cm² (0.30 mm²).In addition, the implant was received without its sealed thermoform, and bubbles were observed within the gel measuring approximately 0.9 cm x 0.6 cm and 0.4 cm x 0.2 cm, within specification.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional investigation was performed to identify the chemical composition of the foreign matters.The investigation concluded that particles a and b (0.05 mm² and 0.05 mm²) revealed that foreign material particles exhibited the infrared spectrum for biological/based material, with residues from breast implant (pdms).In the other hands, particle c (0.30 mm²) exhibited the composition of a siloxane base material.However, the source of origin for the particles analyzed remains unknown.The identification and characterization of the foreign material observed were compared to an existing toxicology report.The assessment concluded that the identified material, will not alter the biocompatibility profile of the finished product.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through mentor¿s quality system.The mentor microbiology department provided the sterility assurance records of the device.The lot met all the sterilization parameters required to provide sterility assurance prior to release for distribution.According with the manufacturer's investigation, all three particles were measured to be within mentor's specifications of acceptable particles in the shell.

• 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 15632762
• Report Number: 1645337-2022-12557
• Device Sequence Number: 8008089
• Product Code: MRD
• UDI-Device Identifier: 10081317030666
• UDI-Public: 10081317030666
• 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

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: RSZHPB325S
• Device Catalogue Number: RSZHPB325S
• Device Lot Number: 9713829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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