MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J740D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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: could you please provide lot number? - qjmjsk.Did all the pieces with this issue had the same lot number? - yes.Device return follow up.- device left in materials office still awaiting shipping kit to send back.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2021-05672, 2210968-2021-05673 and 2210968-2021-05675.
Event or Problem Description
It was reported that the patient underwent a lumbar fusion procedure on (b)(6) 2021 and the suture was used.During use, the needle was popping off the sweg too easily.The procedure was completed with another like suture with no patient consequences.
Additional Manufacturer Narrative
Date sent to the fda: 08/11/2021.Additional h6 component code: g07002 ¿ reported condition not confirmed.A manufacturing record evaluation was performed for the finished device lot number qjmjsk/ j740d05, and no non-conformances related to the reported complaint condition were identified.Additional h-3 summary: two empty foils packets and four packets of product code j740 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, the four 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 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 meets the requirements.Additional product was received to product code j775 from other lot (not involved in the event): two empty foils packets and three packets of product code j775 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, the three 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 on the suture and no defects were observed during evaluation.Functional test was performed, and the pull force result meets the requirements.A manufacturing record evaluation was performed for the finished device lot number qlmaer / j775d05, and no non-conformances related to the reported complaint condition were identified.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 # (b)(4).Date sent to the fda: 07/22/2021.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 device not returned.Device history lot: a manufacturing record evaluation was performed for the finished device lot number qjmjsk, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: VCL CT BRD VIO 8X18IN 0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12028769
• Report Number: 2210968-2021-05674
• Device Sequence Number: 11106374
• Product Code: GAM
• UDI-Device Identifier: 10705031042636
• UDI-Public: 10705031042636
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2021

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: 07/31/2025
• Device Model Number: J740D
• Device Catalogue Number: J740D
• Device Lot Number: QJMJSK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/22/2021; 07/23/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/22/2021; 08/11/2021
• Patient Sequence Number: 1