MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 27IN 3-0 S/A FS-1; SUTURE, ABSORBABLE, NATURAL

Model Number H810H

Device Problems Break (1069); Defective Component (2292)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure in (b)(6) 2022 and suture was used.During the procedure, the suture broke.No adverse patient consequences were reported.Additional information was requested.

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 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.Please provide the specific number of patient events: did the event occurred during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If this event occurred in multiple procedures, please provide information requested above for each patient event.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).What are the procedure name(s) and date(s)? what is the quantity involved per procedure was there any adverse patient consequence(s) or subsequent medical/surgical intervention? events reported via 2210968-2022-07416, 2210968-2022-07417, 2210968-2022-07418, and 2210968-2022-07419.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/28/2022.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: did the event occurred during one or multiple patient procedures? the event has occurred during multiple patient procedures.What is the total number of procedures? i am unsure of the total number of procedures, i would range it between 60-80 patients we have had issues with sutures.If this event occurred in multiple procedures, please provide information requested above for each patient event.I do not have a record of each patient that this has happened to, there have been several since we received this shipment of sutures.What are the procedure name(s) and date(s)? we have been using them during wisdom teeth extractions, and single teeth extractions.What is the quantity involved per procedure we would typically use 1 suture per procedure was there any adverse patient consequence(s) or subsequent medical/surgical intervention? no, it has just added time onto each procedure as dr.(b)(6) has had to redo some sutures multiple times.Dr.Shaffner has also mentioned that the sutures are just very inconsistent, some areas seem to be ok on the thread and others are very thin and keep tearing.Additional information was requested: have these events been previous reported? 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.Events reported via 2210968-2022-07416, 2210968-2022-07417, 2210968-2022-07418, and 2210968-2022-07419.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 10/18/2022.H6 component code: c22 - photo analysis.H6 component code: g07002 no device returned.Additional information was requested, the following was obtained: have these events been previous reported? no, they have not.H3 investigational summary ¿ photo analysis: this is an analysis of a photo submitted to ethicon for review.During the visual analysis the following was observed: the photographs show the suture had broken into several pieces.The photo does not provide enough evidence to determine the root cause.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be 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.Reported events: 2210968-2022-07415, 2210968-2022-07416, 2210968-2022-07417, 2210968-2022-07418, and 2210968-2022-07419.

• Brand Name: GUT PL UD 27IN 3-0 S/A FS-1
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15403411
• MDR Text Key: 305738042
• Report Number: 2210968-2022-07415
• Device Sequence Number: 1
• Product Code: GAL
• UDI-Device Identifier: 10705031037755
• UDI-Public: 10705031037755
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: H810H
• Device Catalogue Number: H810H
• Device Lot Number: SAMPMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1