MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 5IN 9-0 S/A V100-3; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	2894G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If further details are received at a later date a supplemental medwatch will be sent.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 (b)(6) 2020, and a suture was used.During the procedure, the suture broke.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 12/4/2020.Additional h6 component code: g07002 - conforming device.A manufacturing record evaluation was performed for the finished device pek063 batch number, and no non-conformances were identified.Additional h3 investigation summary: two opened boxes with a total of seven-teen unopened samples of product code 2894g lot # pek063 were received for evaluation.During the visual inspection of thirteen unopened samples, no defects were found on the package.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 strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.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 returned for analysis.The following information was requested but unavailable: how many sutures were broken during suturing on this one patient during this single surgical procedure? what was used to complete the procedure? what tissue was being approximated or sutured when it broke? did the suture broken issue in lot number pek063 in 2 boxes occur in multiple procedures? if yes, please provide pc number for each of the procedures procedure name and date? note: events reported via mw # 2210968-2020-08656, 2210968-2020-08657.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, or its employees that the report constitutes an admission that the product, ethicon, 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 5IN 9-0 S/A V100-3
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10785246
• Report Number: 2210968-2020-08657
• Device Sequence Number: 19867413
• Product Code: GAR
• UDI-Device Identifier: 10705031004276
• UDI-Public: 10705031004276
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 04/30/2024
• Device Model Number: 2894G
• Device Catalogue Number: 2894G
• Device Lot Number: PEK063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1