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

Model Number	RSZSHPX700S
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
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: procedure prolonged due to sizer rupture.Concomitant products: (b)(4).
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation with a mentor memorygel xtra resterilizable gel sizer on (b)(6) 2019.The sizer was implanted without issue.However, when the surgeon tried pulling the sizer out, the device was ruptured.The surgeon had to pull the sizer out in pieces.As a result, the procedure was prolonged by approximately 45 minutes as the surgeon had to washout the implant pocket and perform a debridement of the loose silicon.The procure was then completed as planned.These devices are not subject to medical device reporting regulations; however, mentor is submitting this report due to the nature of the event.
Additional Manufacturer Narrative
On (b)(6) 2019, mentor 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.Manufacturer reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, the product investigation was completed.Device investigation summary: during visual inspection of the device, a tear was observed in the posterior view, measuring approximately 4.0 cm.Microscopic examination was performed and the cause of the rupture could not be identified.The silicone elastomer shell may easily be cut by scalpel or ruptured by excessive stress, manipulation with blunt instruments or penetration by a needle.Therefore, the use of forceps or hemostats is specifically contraindicated as shell damage may lead to rupture of the gel sizer.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.Manufacturer's reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZER
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9344853
• Report Number: 1645337-2019-24170
• Device Sequence Number: 16686152
• Product Code: MRD
• UDI-Device Identifier: 00081317026334
• UDI-Public: 00081317026334
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2024
• Device Model Number: RSZSHPX700S
• Device Catalogue Number: RSZSHPX700S
• Device Lot Number: 9363379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 12/27/2019; 03/24/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/30/2019; 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention