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

Catalog Number NW9262

Device Problems Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Additional information was requested and the following was obtained: what was the initial procedure? - hemicolectomy (abdominal closer).What was used to complete the procedure? - dr completed the procedure by using the competitor's product.Did the surgery was completed successfully? - yes.Did the patient suffer from any consequence due to the issue (pull off suture needle)? -no.Could you please confirm how many devices present the issue (pull off suture needle)? -1.Investigation summary: product complaint (b)(4) was logged in for voc performance-pull off suture needle on dt 2020.Below is the detailed analysis of retain sample against mentioned voc.Manufacturing records review: 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 card 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-pull off suture needle, needle pull test is applicable & measurable parameter.Needle pull-off test was performed over five retain samples to check the behavior of the swaging process.The average needle pull value of the retain sample was found to be 7.254 kgf and value at release was found to be 5.810 kgf which meets the average in-house requirement i.E.Nlt 1.840 kgf.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 needle pull test and found to meet the specification.All the individual as well as average needle pull-off values 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.Hence the complaint could not be confirmed.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the suture got detached from the needle.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 04/09/2021.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.Updated investigation summary : complaint sample: 1 unit of actual complaint sample foil along with needle and suture received for investigation for code nw9262 lot t9040.Suture received in partial disintegrated condition.As the complaint sample received in open condition 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 found to be rusted at various places, several instrument holding marks were also observed.Manufacturing records review: 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 card review, it has been observed that there was no issue related to the suture quality and processing of this incident lot.Retained sample evaluation: five retain samples of incident code nw9262 and lot t9040 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 needle pull test and found to meet the specification.As the complaint is related to performance-pull off suture needle, needle pull test is applicable & measurable parameter.Needle pull-off test was performed over five retain samples to check the behavior of the swaging process.All the individual as well as average needle pull-off values 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 detected detachment of suture issue may have been observed due to ingress of humidity through the observed pinholes.The observed pin holes might have generated during improper storage and handling of the product.Device history batch :dhr: (b)(4) batch manufacturing records of (b)(4) was reviewed for any process deviation but no deviation was observed.Finished goods tests reports was reviewed for tensile strength value and needle pull-off value found to meet the specification requirement.Corrected information: d3, g1.

• Brand Name: ABSORBABLE SURGICAL SUTURE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11111541
• MDR Text Key: 226069162
• Report Number: 2210968-2021-00007
• 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
• Report Date: 12/11/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: NW9262
• Device Lot Number: T9040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 04/09/2021
• Patient Sequence Number: 1