MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 7-0 S/A P-6 PRM; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1647G
Medical Device Problem Code	Break (1069)
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).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.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.The following information will be requested from bq: for this initial report (b)(4), - were there patient consequences? if yes, please explain.- please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.It was reported that "¿the phenomenon of the thread constantly breaking is causing inconvenience in use." - please confirm, did multiple suture devices break during use in one procedure? *if yes, - how many devices demonstrated the alleged deficiency? - when did the sutures break (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? - please confirm, did multiple suture devices broke during use on multiple procedures? *if yes, - please confirm the number of patients affected by this alleged deficiency? - have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If no, please create a new pc file for each patient/event.Please provide information requested below for each patient/event.- were there patient consequences? if yes, please specify.- how many devices demonstrated the alleged deficiency? - when did the sutures break (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? - what are the procedure name(s) and date(s)? - can you identify the lot numbers and product code of the product that was used? - please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).- please confirm if the devices are available for product return.If yes, please confirm the number of devices available to be returned for product analysis and perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2025 and suture was used.During the procedure, the phenomenon of the thread constantly breaking is causing inconvenience in use.There were no adverse reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (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.Additional information: d9, h3, h6.H3 investigation summary (b01): the product was returned to ethicon for evaluation.One empty open folder and one needle-suture piece was received for analysis.Product code 1647g.During the initial inspection of the sample, no breakage suture was observed.But the extreme was noted to be cut probably caused by a surgical instrument.The other section of the suture was not returned for analysis.The functional test was not possible because the suture was received with a short length.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: the instructions for use contained the following caution: as with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.The event described could not be confirmed.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 h3 investigation summary (b03): the product was returned to ethicon for evaluation.Six unopened samples and one empty box were returned for evaluation.Product code 1647g.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 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.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 breakage suture 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.Additional h3 investigation summary (b03): the product was returned to ethicon for evaluation.Two unused needle-suture combinations were received for analysis.Product code 1647g.In order to evaluate the condition of the returned sample the swage and attachment area were noted to be as expected.The sutures were examined along the strand to detect any issue related to the customer complaint and no defects were observed during 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.The event described could not be confirmed as 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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.

• Brand Name: ETHLN BLK 18IN 7-0 S/A P-6 PRM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 21689395
• Report Number: 2210968-2025-03134
• Device Sequence Number: 13088327
• Product Code: GAR
• UDI-Device Identifier: 10705031001589
• UDI-Public: (01)10705031001589(17)46873(10)TEMHKH
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 1647G
• Device Lot Number: TEMHKH
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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