MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 5-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J421H
Medical Device Problem Codes	Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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 procedure in 2019 and suture was used.The needle detached from the suture and the suture frayed during use.The procedure was delayed five minutes.A substitute suture was used to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number pa6676, and no non-conformances were identified.Additional investigation summary: one opened sample of product code j421, lot pa6676 was received for analysis.The complaint sample was not received for analysis.During the visual inspection of the unused sample, the swage and attachment area were noted to be as expected.The suture was examined along of the strand and no defects or fraying suture 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 pull off suture needle or fraying suture intra-op was found, and the tested sample met the finished goods requirements.Additional investigation summary: one opened box with unopened samples of product code j421, lot pa6676 was received for analysis.The complaint sample was not received for analysis.During the visual inspection of samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects or fraying suture 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 samples, no pull off suture needle or fraying suture intra-op was found, and the tested samples met the finished goods requirements.

• Brand Name: VCL CT BRD UD 27IN 5-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9261875
• Report Number: 2210968-2019-89322
• Device Sequence Number: 11276482
• Product Code: GAM
• UDI-Device Identifier: 10705031039711
• UDI-Public: 10705031039711
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: J421H
• Device Lot Number: PA6676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 10/06/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/15/2019
• Patient Sequence Number: 1