MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	642G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).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.Additional information was requested and the following was obtained: please clarify how many sutures separated from the needle during suturing on this one patient during this single surgical procedure? 10.Can you please provide lot number for each product involved? rcbbst.Please provide procedure name and date: no further information is available.Please provide status of product return: we regularly contact with sales rep about the device returning.No further information will be provided.Note: events reported in 2210968-2021-05898, 2210968-2021-05900, 2210968-2021-05901, 2210968-2021-05902, 2210968-2021-05903, 2210968-2021-05904, 2210968-2021-05905, 2210968-2021-05906, and 2210968-2021-05907.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture detached from needle easily.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Pc(b)(4).Date sent to the fda: 8/31/2021.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 manufacturing record evaluation was performed for the finished device batch rcbbst, and no non-conformances were identified.Visual analysis of the returned product revealed that one empty labeled winding former and a needle/suture piece product code 642 were received for evaluation.Upon visual inspection of the returned sample, the swage and attachment area were noted as expected and the needle still was attached to the suture.Upon visual inspection, the suture was to be damaged at the surface, in addition, the end was observed cutted.After further evaluation crimping marks were observed on the surface suture possibly from a surgical instrument.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.An opened box with three packets of product code 642 were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, the three packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand to detect any issue on the suture and no defects were observed during evaluation.Functional test was performed, and the pull force result were above the minimum requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: ETHILON SUTURE 18"(45CM) 3-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12084490
• Report Number: 2210968-2021-05899
• Device Sequence Number: 14328371
• Product Code: GAR
• UDI-Device Identifier: 10705031007420
• UDI-Public: 10705031007420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 642G
• Device Catalogue Number: 642G
• Device Lot Number: RCBBST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: 06/06/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/31/2021
• Patient Sequence Number: 1