MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 3-0 D/A V-4; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X926H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been 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.Note: events reported in 2210968-2020-03828, 2210968-2020-03829 and 2210968-2020-03837 it was reported that the ¿needle pulling off suture issue occurred three time this week¿ when did the issue occur; in the package/ during dispensing (before use on patient/during actual suturing (use on patient)? procedure name, initial procedure date the event occurred.Lot number device return status/follow up.Attempts have been made to retrieve the device.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 on an unknown date and suture was used.During the procedure, the needle pulled off the suture.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/11/2020.H10 comment reported in the initial mw: note: events reported in 2210968-2020-03829, 2210968-2020-03834 and 2210968-2020-03837.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/18/2020.A manufacturing record evaluation was performed for the finished device lot number ppmhrc, and no non-conformances were identified.Additional h3 investigation summary: one open sample of product code x926, lot ppmhrc was received for analysis.The product code is double armed.During the visual inspection of detached needle, the swage and attachment area were as expected.The barrel hole was examined under magnification and remnant suture was noted.The suture end is severely cut, resulting in a clip off defect.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of the pull off - suture needle, is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.Two unopened samples of product code x926, lot ppmhrc were received for analysis.The product code is double armed.During the visual inspection of two 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 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 performance pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: EB EXC GRN 30IN 3-0 D/A V-4
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10044155
• Report Number: 2210968-2020-03837
• Device Sequence Number: 3867467
• Product Code: GAT
• UDI-Device Identifier: 10705031058330
• UDI-Public: 10705031058330
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• 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,Followup
• Report Date (Section B): 05/01/2020

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: 11/30/2024
• Device Model Number: X926H
• Device Catalogue Number: X926H
• Device Lot Number: PPMHRC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 05/01/2020; 05/13/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 05/11/2020; 05/18/2020
• Patient Sequence Number: 1