MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 12IN 4-0 S/A M-1; SUTURE, ABSORBABLE, NATURAL

Model Number	742G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date in 2021 and suture was used.During the procedure, the suture kept breaking.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device not returned.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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 is the total number of patients? 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)? if complaints have not been reported, please create a complaint for each single event & patient.Please provide lot number when did the suture broke, before use on patient (pre-op), during use on patient (intra-op)or after use on patient (post-op)? how many sutures broke during each single surgical procedure? please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail how was procedure successfully completed?.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/3/2022.H6 component code: g07002 no device return.The following additional information was requested, but unavailable: was it happened in single procedure or multiple procedure? what is the total number of patients? have any of these events been previously reported to us? if so, provide the respective reference number(s).What are the procedure name(s) and date(s)? if complaints have not been reported, we need to create a complaint for each single event & patient.Please confirm.When did the suture broke, before use on patient (pre-op), during use on patient (intra-op)or after use on patient (post-op)? how many sutures broke during each single surgical procedure? please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail.How was procedure successfully completed? please provide lot number."i have no further info to add to this complaint." 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.

• Brand Name: GUT PL UD 12IN 4-0 S/A M-1
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13168740
• Report Number: 2210968-2022-00078
• Device Sequence Number: 5365343
• Product Code: GAL
• UDI-Device Identifier: 10705031009615
• UDI-Public: 10705031009615
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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 Model Number: 742G
• Device Catalogue Number: 742G
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 01/09/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown