MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	699H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 obtained: was the needle removed from the patient during the same procedure? yes what tissue/location was suturing when pull-off occurred? pulling through the skin please provide the lot number for the involved device.In device comments as it didn¿t pull up leh544 please provide the procedure date.(b)(6) 2021.
Event or Problem Description
It was reported that the patient underwent a biopsy procedure on (b)(6) 2021 and the suture was used.During skin closure, the suture pulled out from the swaged end of the needle on the first pass with minimal tension.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 06/22/2021.H6 component code: g07002 - device not returned.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.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: ETHLN BLK 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11884722
• Report Number: 2210968-2021-04992
• Device Sequence Number: 14394659
• Product Code: GAR
• UDI-Device Identifier: 10705031008632
• UDI-Public: 10705031008632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2021

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: 04/30/2022
• Device Model Number: 699H
• Device Catalogue Number: 699H
• Device Lot Number: LEH544
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/22/2021
• Patient Sequence Number: 1