MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 7-0 D/A BV175-7 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8766H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	01/18/2024
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.Component code: g07002 device not returned attempts have been made to retrieve the device.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.Were all 12 sutures used in this one patient procedure? if no, please clarify how many sutures were used and include the number of sutures per product code for this patient.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index (initial) 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 originally tied (multiple knots, square knot, etc.)? what date did the patient present with symptoms? what describe the symptoms the patient experienced following the index surgical procedure.Please explain "fibrosis of suture".Did the suture fray post op? did the suture broke post op? what was the date of the second procedure? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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? will product be returned? if so, please provide the return date and tracking information.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Related events reported via 2210968-2024-02889, 2210968-2024-02890, 2210968-2024-02891, 2210968-2024-02892, 2210968-2024-02893, 2210968-2024-02894, 2210968-2024-02901, , 2210968-2024-02903, 2210968-2024-02904, 2210968-2024-02905, 2210968-2024-02906.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Fibrosis of the suture used to make anastomosis on the aorta was reported.The patient underwent reoperation.A seam of the same type was used to complete the procedure.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 h3 investigation summary: the product was returned to ethicon for evaluation.The returned product determined that it was received sixteen unopened samples that pertained to the product code 8766h.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were examined for visual defects: appearance, color package, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured) and none was observed.The packets were opened, and the swage and attachment area were noted to be as expected.During the visual inspection, the sutures were correctly placed on the winding former.The sutures were dispensed without problem and examined along the strand and no anomalies or damage on the suture surface could be observed.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on the cause of the reported event.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PRLNE BLU 24IN 7-0 D/A BV175-7 MP
• 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: 18886332
• Report Number: 2210968-2024-02902
• Device Sequence Number: 15338332
• Product Code: GAW
• UDI-Device Identifier: 10705031020382
• UDI-Public: 10705031020382
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/29/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8766H
• Device Lot Number: TEBDCP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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 Sex: Unknown