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

Model Number	SHPX235
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 235cc mentor memorygel breast implant ruptured intra-operatively.There was no patient consequence or adverse event reported.As a result, a new 235cc mentor memorygel breast implant (catalog: shpx235 lot: 9578327, sn:(b)(4)) was implanted instead.
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).
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.(b)(4).
Event or Problem Description
It was reported that a 235cc mentor memorygel breast implant ruptured intra-operatively.There was no patient consequence or adverse event reported.As a result, a new 235cc mentor memorygel breast implant (catalog: shpx235 lot: 9578327, sn:(b)(4)) was implanted instead.
Additional Manufacturer Narrative
On april 13, 2022, 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.
Additional Manufacturer Narrative
On may 1, 2022, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample determined that the smooth high profile xtra 235cc breast implant was found to be ruptured.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear on the posterior view, measuring less than 0.1 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13553093
• Report Number: 1645337-2022-01781
• Device Sequence Number: 11695880
• Product Code: FTR
• UDI-Device Identifier: 00081317025214
• UDI-Public: 00081317025214
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Distributor
• 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: 05/21/2026
• Device Model Number: SHPX235
• Device Catalogue Number: SHPX235
• Device Lot Number: 9578327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 04/13/2022; 05/01/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/29/2022; 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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