MAUDE Adverse Event Report: ETHICON INC. NON ABSORBABLE SURGICAL SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number NW844

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 10/12/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent a pediatric cardiac surgery procedure on (b)(6)2021 and suture was used.The suture broke and the needle bent.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

(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.Additional information was requested and the following was obtained: how many sutures broke and needles bent during this single procedure for nw844 and no lot number in each box? (prolene 2-0 nw844/ lot.-v0003 / qty- 3 and prolene 2-0 nw844/ lot.-v9017 / qty -1) would you please review if the unit of measure is each and not sales unit (box)? each.Did the event occur before (pre op) or during the procedure (intra op)? intra-op.Did the needle bent and suture breakage occurred during multiple procedures? if yes, please provide pc number for each of the procedures.It happened in the same procedure.Procedure date? (b)(6) 2021.Lot number? prolene 2-0 nw844/ lot.-v0003 / qty- 3 and prolene 2-0 nw844/ lot.-v9017 / qty -1.Event related to mw # 2210968-2021-11163, mw # 2210968-2021-11164, mw # 2210968-2021-11166.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: complaint sample: 04 opened units of code nw844 lot v9017 (01 unit) and for lot v0003(03 units) were received as a complaint sample for investigation.Complaint sample consisted of 04 zipper trays, 04 zipper lids suture strands, 04 needles.As the complaint sample received in open condition further investigation on complaint sample was not performed except visual inspection.Received complaint sample was visually inspected under magnification and it has been observed that all the suture strands had punch marks at multiple places which indicated that the suture was handled or dispensed with force.Received needles were visually inspected under magnification and it has been observed that several user instrument marks and bent up appearance right behind the bend area were observed.This indicated that the needles were grasped with force.Retained sample evaluation: five retain samples of incident code nw844 and lot v0003 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.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 was found to meet the average knot pull tensile strength requirement.Five retain samples of each raw needle were retrieved for analysis.The needle retain samples were visually inspected for physical appearance, curvature, point, length etc.Attribute defects such as bend, cracked barrel, fins, and were found satisfactory.Bore diameter, wire diameter, and bore depth test results were found to be meeting specification requirement.No defects were observed in the retain sample testing.These retain samples were tested for % stiffness test & ductility test and found to meet specification requirement.Stiffness test was performed to check the behavior of the needle material and process control.All individual stiffness values were found to be above in-house specification requirement for %stiffness test meeting stiffness minimum individual in-house requirement.Further ductility test was performed to check the behavior of the needle material and process control.All individual ductility test values were found to be above in-house specification requirement for ductility test meeting minimum individual in-house requirement.All the individual as well as average knot pull tensile strength test values as well as needle visual inspection, needle stiffness and ductility test values were found to meet the specification requirements.This analysis shows that there was no issue related to processing of the lot.All the values are within the control limits.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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, or its employees that the report constitutes an admission that the product, ethicon, 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 ¿ visual inspection of returned sample.

• Brand Name: NON ABSORBABLE SURGICAL SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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 43113 3; IN 431133
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12784001
• MDR Text Key: 285493841
• Report Number: 2210968-2021-11165
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: NW844
• Device Lot Number: V0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1