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

Model Number	J305H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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: lot number? procedure name and date? event date? did the pull off event occurred before the procedure (pre op) or during the procedure (intra op)? please clarify if the quantity involved are 2 devices for product code j305h experienced needle pull off during this one procedure? and quantity involved are 12 devices for product code 8557h which also experienced needle pull off during this one procedure? 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.Related reports: 2210968-2021-12731, 2210968-2021-12732, 2210968-2021-12734, 2210968-2021-12735, 2210968-2021-12736, 2210968-2021-12737, 2210968-2021-12738, 2210968-2021-12739, 2210968-2021-12740, 2210968-2021-12741, 2210968-2021-12742, 2210968-2021-12743, 2210968-2021-12744.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle and suture were separated.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/11/2022.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.The following information was requested, and the following was obtained: lot number? unknown.Procedure name and date? unknown.Event date? unknown.Did the pull off event occurred before the procedure (pre op) or during the procedure (intra op)? unknown.Please clarify if the quantity involved are 2 devices for product code j305h experienced needle pull off during this one procedure? and.This product code is not involved in this customer complaint quantity involved are (b)(4) devices for product code 8557h which also experienced needle pull off during this one procedure?.

• Brand Name: VCL CT BRD VIO 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13040159
• Report Number: 2210968-2021-12733
• Device Sequence Number: 1792536
• Product Code: GAM
• UDI-Device Identifier: 10705031038639
• UDI-Public: 10705031038639
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2021

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 Model Number: J305H
• Device Catalogue Number: J305H
• 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: 11/21/2021
• Supplement Date Received by Manufacturer: 12/19/2021
• Initial Report FDA Received Date: 12/18/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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