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

Model Number	J351H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.
Event or Problem Description
It was reported that a patient underwent an unknown ob-gyn surgery on an unknown date and the suture was used.During surgery, the suture was detached from the needle during use.It was not a control release needle.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Date sent to the fda: 04/21/2020.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional h-3 summary: one empty winding former and a detached needle of product were received for analysis.During the visual inspection of the needles, the swage and attachment area were noted to be as expected.No remnant of the suture was noted into the barrel hole; however, marks were observed on the edge of the needles that appears to be by the use of a surgical instrument.In addition, the suture was not returned for analysis.Per the sample condition the assignable of the performance pull off - suture needle, suggest an improper handling of the sample.

• Brand Name: VCL CT BRD VIO 27IN 2-0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9875275
• Report Number: 2210968-2020-02323
• Device Sequence Number: 3183453
• Product Code: GAM
• UDI-Device Identifier: 10705031039162
• UDI-Public: 10705031039162
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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 Expiration Date: 07/31/2024
• Device Model Number: J351H
• Device Catalogue Number: J351H
• Device Lot Number: PJK622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1