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

Model Number	J269H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).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 the single complaint was reported with multiple events.There are no additional details regarding the additional events.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.Were there any patient consequences? please specify.Which tissue layer, at which location was the suture, was used to close? the amount of time between the suture placement and the "pre absorption"? did the operating surgeon observe any suture deficiency or anomaly before, during or after its use in the patient? what are the lot numbers for product codes j269h, j441h? procedure name and date? event date? it was reported that "this has happened in more than one case with more than one physician." were these cases reported to ethicon previously? please provide complaint numbers.If not, please provide details for each event occurred.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 2210968-2020-08173.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2020 and the suture was used.It was reported that the suture was not absorbing long after it is supposed to.They checked back months later and still found suture.Strays of suture left on patient.There were no patient consequences reported at this time.Additional information was requested.

• Brand Name: VCL CT BRD UD 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10710889
• Report Number: 2210968-2020-08172
• Device Sequence Number: 3482941
• Product Code: GAM
• UDI-Device Identifier: 10705031038431
• UDI-Public: 10705031038431
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: J269H
• Device Catalogue Number: J269H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1