MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J215H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).H6 component code: g07002 - device not returned.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.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 via: 1.How many sutures that needles pop off issue during this single procedure? approximately 8-10 sutures malfunctioned.2.Please clarify when the event occurs (pre-op, intra-op, post-op) the event occurred intra operatively 10/23/23 and 10/25/23.3.Please clarify if all the devices are from the same lot number.All the devices were lot # thmemd.4.Any patient consequences? no harm came to the patients.5.Status of product return.The actual sutures had been tossed in the sharps container.I have the outer packages from 2 of the sutures.The rest had already been thrown out before it was brought to my attention.Attempts are being made to obtain 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.It was reported that "the event occurred intra operatively 10/23/23 and 10/25/23." can you please confirm that the needle pull off issue occurred during one single procedure? -was there a second procedure involving with the same patient? please clarify, since two events dates were reported.Events reported via: 2210968-2023-09405, 2210968-2023-09396, 2210968-2023-09397, 2210968-2023-09398, 2210968-2023-09399, 2210968-2023-09400, 2210968-2023-09402, 2210968-2023-09403, 2210968-2023-09404.
Event or Problem Description
It was reported that a patient underwent an unknown surgery in 2023 and suture was used.During the procedure, it was reported by the distributor that the needles kept popping off the suture.Devices are available for return.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/28/2023 a review of the batch manufacturing records was conducted, and no related non-conformances 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.Related reports: 2210968-2023-09405, 2210968-2023-09396, 2210968-2023-09397, 2210968-2023-09398, 2210968-2023-09399, 2210968-2023-09400, 2210968-2023-09402, 2210968-2023-09403, 2210968-2023-09404.

• Brand Name: VCL CT BRD UD 27IN 3-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18253017
• Report Number: 2210968-2023-09401
• Device Sequence Number: 12423055
• Product Code: GAM
• UDI-Device Identifier: 10705031038240
• UDI-Public: 10705031038240
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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 Catalogue Number: J215H
• Device Lot Number: THMEMD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown