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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc- (b)(4).The following information was requested, but unavailable: could you please provide the lot number? how was the procedure completed? attempts are being 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 cardiovascular surgery on (b)(6) 2021 and suture was used.During the 1st stitch, after passing the needle through the tissue, the suture was detached from the needle.It was not a control release needle.There were no adverse consequences to the patient.No further information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 05/14/2021.The manufacturing records couldn't be reviewed as the batch number is unknown.Additional h-3 summary: visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample of product code x926h was received for evaluation, the swage and attachment area of the needle were noted with marks, due to use of surgical instrument, and a suture piece still was attached to barrel needle.The end of the suture was cut which appears to be by the use of a surgical instrument could be observed.The functional test could not be performed due to the condition of the sample.The condition of the sample received indicates improper handling of the device.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Date sent to the fda: 05/14/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: EB EXC GRN 30IN 3-0 D/A V-4
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11596073
• Report Number: 2210968-2021-02919
• Device Sequence Number: 19695249
• Product Code: GAT
• UDI-Device Identifier: 10705031058330
• UDI-Public: 10705031058330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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 Model Number: X926H
• Device Catalogue Number: X926H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/14/2021
• Patient Sequence Number: 1