MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 18IN 4-0 D/A SC-1; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1828H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 11/10/2023.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 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.The single complaint was reported with multiple events.Additional information was requested, the following was obtained: please provide an answer for each case: (b)(4): was the first report of issue.(b)(4):made for "several cases".Were there any unexpected outcomes or complications as a result of the prolonged surgery time? suture broke in patient.Needed to use camera to locate it on (b)(6)2023.What tissue was being sutured when the event occurred? these were sinus cases.Was additional dissection required in other organs/tissues other than the target tissue? n/a.Was there any change in the patient¿s post operative care due to the prolonged procedure? no.Did the event occur during one or multiple patient procedures? the suture broke during a case on (b)(6) 2023 and again on (b)(6) 2023.Multiple sutures from the box were tried and broke.Surgeon eventually went to a different suture what is the total number of procedures? 2.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No.Device return status.Please document the shipment tracking number? i do not have this information.Please provide the source or name of person providing answers to follow-up questions:(b)(6), surgery manager.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned samples determined that it was received nine unopened samples that pertain to the product code: 1828h.Upon initial inspection, of the samples, no external damages were observed on the packets.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Related reports: 2210968-2023-08728.
Event or Problem Description
It was reported that a patient underwent a tonsillectomy procedure on (b)(6) 2023 and suture was used.It was reported that in several cases our suture keeps breaking.Delays have been 5-6 minutes.No fragments made.No patient harm.Additional information was requested.

• Brand Name: GUT PL UD 18IN 4-0 D/A SC-1
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18110710
• Report Number: 2210968-2023-08729
• Device Sequence Number: 5556309
• Product Code: GAL
• UDI-Device Identifier: 10705031002661
• UDI-Public: 10705031002661
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

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: 1828H
• Device Lot Number: SKMCKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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