MAUDE Adverse Event Report: ETHICON INC. PROLENE SFT PP MSH 20X20IN 50X50CM; MESH, SURGICAL, POLYMERIC

Catalog Number	SPM3XL
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Failure of Implant (1924); Hernia (2240)
Date of Event	12/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure were any concomitant procedures performed? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? was the index hernia repair associated with this event performed on primary or recurrent hernia? what was the defect size/type/location of the hernia associated with this event? what was the mesh size and overlap? was the procedure associated with this event open or laparoscopic? closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? the mesh fixation technique? (single or double crown; spacing between implants) were there any surgical instruments used in the placement of the mesh that might have damaged the mesh? (e.G.Graspers crimping the mesh fibers) how long after the index hernia repair was the hernia recurrence first noted? was there any triggering event prior to present recurrence? (e.G.Sneezing, coughing, strenuous activity)? how was the recurrence diagnosed? please provide the date and surgical findings from any reoperation performed.Mesh location and integrity at time of reoperation? were any deficiencies or anomalies noted with mesh device during reoperation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product lot number? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.Photo analysis summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show the mesh placement.The image is not clear to determine the failure mode or the reported condition.Based on the photo review, no conclusion or root cause could be determined.Because the instrument was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.The manufacturing records could not be reviewed as the batch number is unknown.
Event or Problem Description
It was reported that a patient underwent a bilateral tar in 2019 and mesh was placed in the retro muscular layer.After an unknown number of years, the patient experienced 5x6cm midline recurrence due to central mesh failure.The surgeon preformed another repair and there are no complications at this point.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following response was received: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure 75 yo male (bmi unknown at the time of index case in 2019).Were any concomitant procedures performed? lysis of adhesions (12 hrs case).What symptoms did the patient experience following the index surgical procedure? onset date? gradual onset of midline bulging with discomfort that started a couple of years after 2019.Other relevant patient history/concomitant medications? no.Was the index hernia repair associated with this event performed on primary or recurrent hernia? multiply recurrent hernia.What was the defect size/type/location of the hernia associated with this event? 5 cm.Wide by 6 cm long defect in the mid abdomen which contained incarcerated omental fat what was the mesh size and overlap? a 10 cm x 15 cm ventralight st was placed in an intraoperitoneal position.Was the procedure associated with this event open or laparoscopic? combined open and robotic.Closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? yes permanent duramesh sutures running (performed open).The mesh fixation technique? (single or double crown; spacing between implants) continuous circumferential stratafix suture.Were there any surgical instruments used in the placement of the mesh that might have damaged the mesh? (e.G.Graspers crimping the mesh fibers)no.How long after the index hernia repair was the hernia recurrence first noted? 5 years.Was there any triggering event prior to present recurrence? (e.G.Sneezing, coughing, strenuous activity)? none.How was the recurrence diagnosed? symptoms, physical exam and imaging studies (ct scan).Please provide the date and surgical findings from any reoperation performed: no reoperation since the central mesh failure was repaired.Mesh location and integrity at time of reoperation? n/a.Were any deficiencies or anomalies noted with mesh device during reoperation? n/a.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unclear why patient had a central mesh failure.What is the patient's current status? doing well post-operatively product lot number? unknown.

• Brand Name: PROLENE SFT PP MSH 20X20IN 50X50CM
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18572712
• Report Number: 2210968-2024-00620
• Device Sequence Number: 7708580
• Product Code: FTL
• UDI-Device Identifier: 10705031238824
• UDI-Public: 10705031238824
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SPM3XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male