MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30IN(75CM) 0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	F2820H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
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 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.(b)(4).Device not returned.Related events captured via 2210968-2022-08035.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.The suture pulled off after 2 passages.A suture from another lot was used to complete the procedure.There were no adverse patient consequences.No further information was provided.
Additional Manufacturer Narrative
Product complaint: (b)(4).Date sent to the fda: 11/8/2022 h6 component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that two detached needles and three suture pieces that pertains to product code f2820h were returned for analysis.Upon visual analysis of the returned sample, the swage and attachment area were noted to be as expected.No suture remnant could be observed in the barrel hole.During the visual inspection of the suture, the ends were cut that appear to be caused by a surgical instrument.After further evaluation marks on the surface were noted due to the handling during use.As per returned conditions of the sample no functional test was performed.The condition of the sample received indicates improper handling of the device.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that one opened box with twelve packets that pertains to product code f2820h was returned to ethicon for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packet.In order to evaluate the conditions of the returned samples, the twelve packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.Functional test was performed using an instron equipment, and the pull force result were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.Related reports: 2210968-2022-0803.

• Brand Name: PROLENE SUTURE 30IN(75CM) 0 BLU
• 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; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15503576
• Report Number: 2210968-2022-08034
• Device Sequence Number: 20155286
• Product Code: GAW
• UDI-Device Identifier: 10705031238008
• UDI-Public: 10705031238008
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 08/31/2026
• Device Model Number: F2820H
• Device Catalogue Number: F2820H
• Device Lot Number: RKBAQS
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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