MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 0 D/A V-7; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X905H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device batch qkmatl, x905h and no non-conformances were identified.The single complaint was reported with multiple events.There are no additional details regarding the additional events.An email has been sent to the customer to obtain more information regarding the recurring issue.Additional information was requested and the following was obtained: how many needles were broken during suturing on this one patient during this single surgical procedure? one.Lot number qkmatl product code x905h quantity involved =1 is this correct? yes.Component code: (b)(4) photo review.The product was not returned to ethicon inc for evaluation.Visual inspection was conducted on the pictures received.Visual analysis of the two pictures received determined that one opened sample of product code x905 (double armed) was received for evaluation.Open channel or pinch an incorrect swage could be observed in the sample.The visual inspection concluded that the needle was twisted at the channel and the pinch is opened.The breakage needle could not be observed on the needles.The open channel or pinch defect has been correlated to the manufacturing process.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Based on the information currently available, the open channel or pinch and incorrect swage were identified during the visual inspection of the picture received.This product issue will be addressed through ethicon inc¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2021 and the suture was used.It was reported that the needle was broken when passing through the skin to make a skin purse.There were no patient consequences.The needle tip fell to the floor.Additional information requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/24/2021.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.H6 component code: g07002 ¿ conforming device.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that thirty-four unopened samples of product code x905h were received for evaluation.Visual inspection of thirteen unopened samples and no defects were found on the packages.The samples were opened, and the closure of the channel area and pinch were noted to be as expected.No needle breakage or bending needle was observed on the body, tip, or swage area.The sutures were dispensed without problems and examined along the strand and no defects were observed.Also, the samples were tested by resistance test to the needle and met the requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The device performed without any defect noted and the actual complaint sample was not received for evaluation.

• Brand Name: EB EXC GRN 36IN 0 D/A V-7
• 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: 11346983
• Report Number: 2210968-2021-01590
• Device Sequence Number: 728442
• Product Code: GAT
• UDI-Device Identifier: 10705031058279
• UDI-Public: 10705031058279
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/26/2021

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 Expiration Date: 08/31/2025
• Device Model Number: X905H
• Device Catalogue Number: X905H
• Device Lot Number: QKMATL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/24/2021
• Patient Sequence Number: 1