MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 5-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J303H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
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.The following information was requested, but unavailable: how was surgery successfully completed? no further information is available.Lot number? no further information is available.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.
Event or Problem Description
It was reported that a patient underwent a plastic surgery on (b)(6) 2021 and suture was used.During the procedure, when passing the needle through the skin, the needle was detached from the suture.It was not a control release needle.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/15/2021.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, or its employees that the report constitutes an admission that the product, ethicon, 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.H3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned sample.Visual analysis of the returned sample determined that an opened sample of product code j303h was received for evaluation.The visual inspection concluded that in the detached needle, the swage and attachment area was noted to be as expected and no suture remnant could be observed at the barrel hole, the end of the sutures was examined and there isn¿t enough impression at the swage end, resulting in a needle pull off defect.The pull-out defect has been correlated to the manufacturing process.According to the procedures is a class 1 defect.This defect is caused when does not tightens the press correctly and the swage area be weak on the needle/suture based on the information currently available, the missing needle/suture was identified during the investigation of the sample received.This product issue will be addressed through quality system.

• Brand Name: VCL CT BRD VIO 27IN 5-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12276654
• Report Number: 2210968-2021-06997
• Device Sequence Number: 3531653
• Product Code: GAM
• UDI-Device Identifier: 10705031038592
• UDI-Public: 10705031038592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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 Model Number: J303H
• Device Catalogue Number: J303H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1