MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 13CM 9-0 BV100-4; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	2829G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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 following information was requested, but unavailable: please clarify the reported device issue 'the suture strand was not properly connected to the needle' was the needle separating form the suture thread? or suture fraying? or other, explain? what was done to manage the 'tearing the vessel wall' ? did the patient have surgical time prolonged, change in procedure or post-op care due to this issue? how was case completed? device return status.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on a unknown date and the suture was used.It was reported that the suture was tearing the vessel wall and when inspected under a microscope it turned out that the suture strand was not properly connected to the needle.A like device from another batch was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/02/2020.Corrected information: d3, g1, g2.Additional information: d10, h6.Additional h3 investigation summary: it was received for analysis an unopened sample of product code w2829, lot phr771.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The suture was examined along of the strand and no defects or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample, no performance pull off suture needle was found, and the tested sample met the finished goods requirements.

• Brand Name: ETHILON BLK 13CM 9-0 BV100-4
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9857277
• Report Number: 2210968-2020-02239
• Device Sequence Number: 2874228
• Product Code: GAR
• UDI-Device Identifier: 10705031004108
• UDI-Public: 10705031004108
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/24/2020

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: 06/30/2024
• Device Model Number: 2829G
• Device Catalogue Number: W2829
• Device Lot Number: PHR771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 06/02/2020
• Patient Sequence Number: 1