MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 18IN 6-0 D/A G-1 PRM; SUTURE, ABSORBABLE, NATURAL

Catalog Number	770G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/3/2025.H6 component code: g07002 - device not returned.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.Additional information was requested, the following information was requested: - how long was the delay? please specify in minutes.- was there any change in the patient¿s post-operative care due to the prolonged procedure? - please confirm, how many needles detach or pull off from the suture thread? - when did the needles detach or pull off from the suture thread (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? - to whom should the replacement be sent? please provide the contact name, department, street address (including zip code), email address, and phone number.Please do not use a p.O.Box.- please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).The delay was an estimated 5-10 minutes.There were no changes to the pt¿s post-op care as a result.There were 3 suture strands that the needle pulled off from while suturing - during passage through the tissue - before they pulled the rest of that box and got another one to finish the procedure with.Sutures will be shipped today and i will send tracing information in a follow up email.Tm, rn is the one providing information regarding this event.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 or Problem Description
It was reported that a patient underwent an eyelid procedure on an unknown date and suture was used.It was reported that oculoplastic surgeon uses a suture for oculoplastic surgery.During surgery the needle was pulling off every suture she used (3 different ones from this box).They took this box out of use and got another one with a different lot number and it worked fine.Surgeon uses this suture all the time so they do not feel it is her technique.They tried 3 different sutures from this box then pulled this box out of use and used sutures from a box with a different lot number.Procedure was completed with a delay of 5-10 minutes.No patient consequences reported.Additional information requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/7/2025.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.H6 component code: g07002 no device problem found.Additional information: d9, h3, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Six unopened samples were received for analysis.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no issues related to pull off - suture needle were noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: GUT PL UD 18IN 6-0 D/A G-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21762540
• Report Number: 2210968-2025-03473
• Device Sequence Number: 12923641
• Product Code: GAL
• UDI-Device Identifier: 10705031010475
• UDI-Public: (01)10705031010475(17)290630(10)102CUM
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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 Catalogue Number: 770G
• Device Lot Number: 102CUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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