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	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot number qjmsxp/ x905h56, and no non-conformances related to the reported complaint condition were identified.Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: was there any patient consequences? no patient consequences.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2021 and the suture was used.During the procedure, the needle broke and a part of the needle was lost but it seems that the needle was lost outside the patient.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 03/26/2021.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.Investigation summary: according to the information received, the tip of the needle broke off.The product was returned to ethicon inc for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that unopened samples of product code x905h were received for evaluation.Visual inspection of unopened samples and no defects were found on the package.The sample was opened, and the swage and attachment area was noted to be as expected.No needle breakage was observed on the body, tip, or swage area.The suture was dispensed without problems and examined along the strand and no defects were observed.Also, the sample was 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.The device performed without any defect noted and the actual complaint sample was not received for evaluation.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• 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: 11387978
• Report Number: 2210968-2021-01830
• Device Sequence Number: 19768842
• 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): 02/02/2021

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: 07/31/2025
• Device Model Number: X905H
• Device Catalogue Number: X905H
• Device Lot Number: QJMSXP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/26/2021
• Patient Sequence Number: 1