MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 30IN 0 S/A FSL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	F2815H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hernia (2240); Insufficient Information (4580)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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.H6 component code: g07002 device not returned to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 weight, bmi at the time of index procedure.Name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? did the patient experience a wound dehiscence? if yes, what tissue dehisced? were there any patient stress factors that precipitated the event of suture breakage post op? please describe any surgical intervention required for the wound dehiscence including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please describe the appearance of the suture during the second procedure.What symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2024 and suture was used.The suture broke 2 days after surgery.The knots remained in place.The revision surgery was performed on (b)(6) 2024.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (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: h6: health effect - clinical code.Additional information was requested, and the following was obtained: date of index surgical procedure: on (b)(6) 2024.Name of index surgical procedure? cure of peri-stomial eventration by direct approach.The diagnosis and indication for the index surgical procedure? symptomatic peristomal eventration.What was the initial approach for the index surgical procedure? laparoscopic.On what tissue was the suture used? aponeurosis of the rectus abdominis and rectus abdominis muscles.What was the tissue condition (normal, thin, calcified, fragile, diseased)? fragile.How was the suture placed (interrupted or continuous)? interrupted.How was the suture tied (square knot or multiple knots one end)? multiple knots one end.Did the patient experience a wound dehiscence? no.If yes, what tissue dehisced? n/a.Were there any patient stress factors that precipitated the event of suture breakage post op? no.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no suture deficiency or anomaly in pre-op.Early recurrence of the eventration and, on reoperation, discovery of a rupture of all the sutures made with separate stitches.Please describe the appearance of the suture during the second procedure: thread breakage at a distance from the knots.What symptoms did the patient experience following the index surgical procedure? onset date? re-intervention 3 days after the initial procedure for recurrence of eventration.The patient goes well.Other relevant patient history/concomitant medications? no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? a defective lot.Several threads were used during the eventration cure.All broke.What is the patient's current status? the patient goes well.Related medwatch reports: 2210968-2024-01218, 2210968-2024-03073, 2210968-2024-03074 corrected information: h6: type of investigation.

• Brand Name: PROLENE BLU 30IN 0 S/A FSL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18677795
• Report Number: 2210968-2024-01218
• Device Sequence Number: 12566850
• Product Code: GAW
• UDI-Device Identifier: 10705031242111
• UDI-Public: 10705031242111
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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 Catalogue Number: F2815H
• Device Lot Number: SGBDQP
• 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: 01/19/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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: Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male