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

Catalog Number NW9371

Device Problems Break (1069); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2020

Event Type  malfunction  

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.Additional information was requested, and the following was obtained: could you please confirm device's availability? the complaint sample was discarded by the ot staff.A manufacturing record evaluation was performed for the finished device lot t7002, and no non-conformance's were identified.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.

Event Description

It was reported that a patient underwent an laparotomy procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture broke easily while suturing.Another like device was used to complete the procedure successfully without delay.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 12/09/2020.Investigation summary: one video and one photograph was provided for investigation for code: nw9371, lot: t7002.Upon verification of video it has been observed that the sutures were breaking while knotting however lot no and product code cannot be witnessed in video.One complaint sample foil photograph was provided with product code: nw9371, lot: t7002 multiple wrinkles can be witnessed on top side of foil, suture and needle were not present in photograph.Five retain samples of incident codes: nw9371 and lot number: t7002 were retrieved for 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.The primary packs were opened, and sutures and needles were found intact.The sutures were physically inspected for any attribute defects like kinks, weak spots, broken piece, fray, brittleness, detached needles but no such defects were observed.The needles were inspected for any attribute defects like bend, cracked barrel, fins but no such defects were observed.The retain samples were tested for knot pull tensile strength test and found to meet the specification.As a part of further investigation batch manufacturing record was reviewed.The batch manufacturing record was reviewed for any process deviation, but no deviation was observed.Finished good record was reviewed for tensile strength value and needle pull-off value at release and found to meet the specification.From the batch record review, it has been observed that there was no issue related to the suture quality and processing of this incident lot.As the complaint is related to performance-breakage suture, knot pull tensile strength test is applicable & measurable parameter.Knot pull tensile strength test was performed over five retain samples to check the behavior of the suture material.The average knot pull tensile strength value of the retain sample and value at the time of finished good release was found to meet the in-house average knot pull tensile strength requirement.All the individual as well as average knot pull tensile strength values of retain sample were found to meet the in-house specification requirements.This analysis shows that there was no issue related to processing of the lot.All the values are within the control limits.The reported incident was one and isolated case for code: nw9371/t7002.No other event was reported for same description from other parts of country.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.

Manufacturer Narrative

(b)(4).Date sent to the fda: 4/13/2021 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: d9, h6 additional h3 investigation summary: complaint sample: 1 intact unit of actual complaint sample foil along with single barrier folder, needle and suture received for investigation for code nw9371 lot t7002.Complaint sample foil was observed with multiple wrinkles over the whole foil.Suture received in partial to complete disintegrated condition.As the complaint sample foil was observed with multiple wrinkles over the whole foil hence, further investigation on complaint sample cannot be performed except visual inspection.The foil pack was inspected under a 10 x magnification for any damage and showed a multitude of wrinkles over the whole foil along with several pinholes at the top label side as well as on bottom cavity side of the packs were observed.Returned needle was inspected with 10x magnification and no defect was observed.One video and one photograph was provided for investigation for code nw9371 lot t7002.Upon verification of video it has been observed that the sutures were breaking while knotting however lot no and product code cannot be witnessed in video.One complaint sample foil photograph was provided with product code nw9371 lot t7002 multiple wrinkles can be witnessed on top side of foil, suture and needle were not present in photograph.Five retain samples of incident codes nw9371 and lot number t7002 were retrieved for 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.The primary packs were opened, and sutures and needles were found intact.The sutures were physically inspected for any attribute defects like kinks, weak spots, broken piece, fray, brittleness, detached needles but no such defects were observed.The needles were inspected for any attribute defects like bend, cracked barrel, fins but no such defects were observed.The retain samples were tested for knot pull tensile strength test and found to meet the specification.As a part of further investigation batch manufacturing record was reviewed.The batch manufacturing record was reviewed for any process deviation, but no deviation was observed.Finished good record was reviewed for tensile strength value and needle pull-off value at release and found to meet the specification.From the batch record review, it has been observed that there was no issue related to the suture quality and processing of this incident lot.As the complaint is related to performance-breakage suture, knot pull tensile strength test is applicable & measurable parameter.Knot pull tensile strength test was performed over five retain samples to check the behavior of the suture material.The average knot pull tensile strength value of the retain sample and value at the time of finished good release was found to meet the in-house average knot pull tensile strength requirement.All the individual as well as average knot pull tensile strength values of retain sample were found to meet the in-house specification requirements.This analysis shows that there was no issue related to processing of the lot.All the values are within the control limits.The reported incident was one and isolated case for code nw9371/t7002.No other event was reported for same description from other parts of country.(b)(4) date sent to the fda: 4/13/2021.

• Brand Name: ABSORBABLE SURGICAL SUTURE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 10704901
• MDR Text Key: 212138986
• Report Number: 2210968-2020-08132
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: NW9371
• Device Lot Number: T7002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1