MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 12IN 7-0 D/A TG140-8; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J566G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional information was requested and the following was obtained: please clarify what is the specific issue with the device during this procedure? the suture broke during the procedure.Did the suture detach from the needle? no, it snapped a couple inches from the swage.Did the suture also break? yes, the suture broke.Where did the suture break? a couple inches from the swage of the needle.Did the suture only break at the point that it is attached to the needle? did the needle prematurely releases from the suture strand during use? yes.Lot number? not provided.Events reported in medwatch report: (b)(4).
Event or Problem Description
It was reported that a patient underwent a urological procedure in 2021 and suture was used.During the procedure, the suture snapped.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 04/09/2021.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.Additional information: d4, d9, g1, h4.Investigation summary: according to the information received, it was reported by the rep during a pediatric urological procedure the suture snapped during the procedure.The product was returned to ethicon inc for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample (a needle/suture piece) of product code j566 was received for evaluation, the swage and attachment area was noted to be as expected, the suture end was cut appears to be by use of the surgical instrument.The product code j566 contains absorbable suture and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.The condition of the sample received indicates improper handling of the device.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Device history lot: a manufacturing record evaluation was performed for the finished device lot number qmmacq / j566g50, and no non-conformances related to the reported complaint condition were identified.Corrected information: d3, g1.

• Brand Name: VCL CT BRD VIO 12IN 7-0 D/A TG140-8
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11464180
• Report Number: 2210968-2021-02251
• Device Sequence Number: 3523896
• Product Code: GAM
• UDI-Device Identifier: 10705031041264
• UDI-Public: 10705031041264
• 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
• Report Date (Section B): 02/18/2021

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: 10/31/2025
• Device Model Number: J566G
• Device Catalogue Number: J566G
• Device Lot Number: QMMACQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/09/2021
• Patient Sequence Number: 1