MAUDE Adverse Event Report: ETHICON INC. ABSORBABLE SURGICAL SUTURE; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	NW9254
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).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.What was the initial procedure? could you please confirm when did the issue occurred? pre-op or intra-op did the surgery was completed successfully? if yes what was used to complete the procedure? did the patient suffer from any consequence due to the issue (pull off suture needle)? please explain.Note: events reported in 2210968-2021-10020.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, suture found disintegrated from needle.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 12/2/2021.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 narrative: complaint sample.Complaint sample not received for investigation.Batch manufacturing record review: as a part of investigation batch manufacturing record was reviewed for code nw9254 lot: t8005.The batch manufacturing record was reviewed for any process deviation, but no deviation was observed.Finished good analysis record was reviewed for tensile strength value and needle pull-off value at release and found to meet the specification requirement.From the batch manufacturing record review, it was observed that there were no issues related to the processing of the incident lot.Retain sample evaluation: to verify the complaint, results of retained samples were reviewed.Five retain samples of code lot: nw9254/t8005 were subjected to analysis.The primary packs of retain samples were visually inspected for attribute defects like pseudo seal, pin hole, product in seal, press marks on pack but no such defects were observed.All 05 retain sample primary packs were opened, out of 05 retain samples opened 04 retain sample sutures and needles were found intact.Upon opening of 05th foil of retain sample, needle found detached from suture.Hence needle pull test was not performed on 05th sample.Upon inspection of needle under 10x magnification it has been observed that the suture strand was incorrectly/partially inserted.As a result of incorrect/partial insertion the suture strand may have got separated prior to testing.Remaining 04 retain samples were visually inspected and tested for needle pull test and found to meet the individual needle pull specification requirement.Average needle pull value of 04 foils tested found to be 4.186 kgf (against avg needle pull requirement ¿ nlt 1.530 kgf).Five retain samples of incident batch were opened for testing where, 01 retain sample failed to meet the specification requirement.Based on the analysis it is evident that this is a confirmed manufacturing defect complaint.Results for needle pull test were not complying with the pre-defined acceptance criteria.Further actions will be taken as per local qms procedures and file will be updated accordingly.Retain sample photographs: supply chain records were reviewed, and it has been observed that the product was distributed in same region by johnson and johnson pvt ltd.Raw material test data sheets were reviewed, and the same was found to meet the specification requirement.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/20/2022.Additional information was requested, and the following was obtained: 1.Inguinal hernia (mesh anchoring) * could you please confirm when did the issue occurred? pre-op or intra-op 2.Pre-op * did the surgery was completed successfully? 3.Yes if yes * what was used to complete the procedure? 4.Same material another foil.* did the patient suffer from any consequence due to the issue (pull off suture needle)? please explain.5.No 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.Product complaint # (b)(4).Date sent to the fda: 1/20/2022.B1, h1- additional information received that indicates this event does not meet reporting malfunction criteria.This event therefore is not reportable.

• Brand Name: ABSORBABLE SURGICAL SUTURE
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-AURANGABAD INDIA; 312379@b-15/1; m.i.d.c., 1 walu; aurangabad ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12666268
• Report Number: 2210968-2021-10021
• Device Sequence Number: 4405904
• Product Code: NEW
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: N18331
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2022

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: 07/31/2023
• Device Catalogue Number: NW9254
• Device Lot Number: T8005
• 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: 09/25/2021
• Supplement Date Received by Manufacturer: 11/10/2021; 12/24/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/02/2021; 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown