MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3-0 S/A CP-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J868H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (b)(4) device not returned.A manufacturing record evaluation was performed for the finished device lot number qkmctx/ j868h50 and no non-conformance's related to the reported complaint condition were identified.Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent additional information was requested, and the following was obtained: what is the lot number?: qkmctx, how many sutures broke? 9 products? 36 products?: 9 products broke, did the 3 surgeons use the broken sutures in the same surgery?: no they had replaced it with an alternative suture, how many patients are involved in this event?: 3.What was used to complete the procedure? ¿ ethicon suture by a different size.Was there any adverse consequence associated with the patient? no.Attempts are being made to clarify 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.Please verify/specify the quantity of suture breakages occurred on one patient during single procedure per each file? procedure name? will be any samples returned? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate events were submitted 2210968-2021-06595, 2210968-2021-06597.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2021 and the suture was used.During use, the suture breakage occurred.Another like suture was used to complete the procedure successfully.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 07/22/2021.Additional information: d4, h4.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 Manufacturer Narrative
Product complaint # = > pc-(b)(4).Date sent to the fda: 9/09/2021 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.H6 component code: g07002 no device problem found additional h3 investigation summary: h3 investigation summary: one opened box with twenty- seven packets of product code j868h were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection of the samples, no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, thirteen packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to damaged or breakage sutures and no defects were observed during evaluation.Functional test was performed, and the tensile strength result was 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 quality process, all devices are manufactured, inspected, and released to approved specifications.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.

• Brand Name: VCL CT BRD UD 27IN 3-0 S/A CP-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12212315
• Report Number: 2210968-2021-06599
• Device Sequence Number: 17246289
• Product Code: GAM
• UDI-Device Identifier: 10705031043329
• UDI-Public: 10705031043329
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K022269
• 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,Followup
• Report Date (Section B): 06/29/2021

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: 08/31/2025
• Device Model Number: J868H
• Device Catalogue Number: J868H
• Device Lot Number: QKMCTX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 08/17/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 07/22/2021; 09/09/2021
• Patient Sequence Number: 1