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

Model Number	J322H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.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 "during the months of (b)(6) and (b)(6) 2021 there were several incidents associated with the violet prolene 0 and vicryl 3-0 sutures, with reports from different physicians indicating that the needle is loosening from the thread (pull off).For the prolene 0 suture, about 10 surgical procedures were reported and for the violet 3-0 vicryl suture, about 5 procedures, the exact number is unknown.".The following files were created to capture ten affected surgical procedures involving prolene 0 sutures and five procedures involving vicryl 3-0: event 1 of 10 prolene - (b)(4) event 2 of 10 prolene - (b)(4) event 3 of 10 prolene - (b)(4) event 4 of 10 prolene - (b)(4) event 5 of 10 prolene - (b)(4) event 6 of 10 prolene - (b)(4) event 7 of 10 prolene - (b)(4) event 8 of 10 prolene - (b)(4) event 9 of 10 prolene - (b)(4) event 10 of 10 prolene - (b)(4) event 1 of 5 vicryl - (b)(4) event 2 of 5 vicryl - (b)(4) event 3 of 5 vicryl - (b)(4) event 4 of 5 vicryl - (b)(4) event 5 of 5 vicryl - (b)(4) for each of the fifteen procedures, please provide the following information: event date, procedure date, procedure name, quantity of product involved.Event description stating when each involved device had a pull off in the procedure.It was mentioned that "the doctors only had difficulties to find the needle, but in the end it was possible to remove it." how was the needle retrieved from the patient? any adverse patient consequences and how were they managed? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the needle got detached from the suture.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 27IN 3-0 S/A MH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12816894
• Report Number: 2210968-2021-11466
• Device Sequence Number: 5512176
• Product Code: GAM
• UDI-Device Identifier: 10705031038783
• UDI-Public: 10705031038783
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 11/15/2021

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: 05/31/2025
• Device Model Number: J322H
• Device Catalogue Number: J322H
• Device Lot Number: AN6884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• 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