MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 5 D/A LR; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	B499T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: please clarify, did the needle break or did the suture break? the needle broke.Was the needle piece(s) retrieved during the same procedure? the pieces were retrieved but discarded.Was more than half of the needle retained in the patient? the needles were removed.What is current condition of the patient? patient is good.Lot number? pending retrieval device return status/follow up? product will be shipped out tomorrow.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 report related to: 2210968-2022-02238.
Event or Problem Description
It was reported that a patient underwent a orthopedic procedure on (b)(6) 2022 and suture was used.During use on the patient it was noted that the needle broke.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).Date sent to the fda: 04/27/2022.H6 component code: g07002.Reported condition not confirmed.This report is being submitted pursuant to the provisions of 21 cfr, part 803.Part 4 subpart b.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.H3 investigation summary: one empty opened box and eight packets of product code b499t were returned for analysis with the packaging closed.Upon initial inspection to the sample no external damage was observed on the packet.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected and no damages, breakage on the body, tip, or swage area were observed.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.Functional test was performed, to needle by resistance and met the requirements.In addition, a functional test was performed using an instron and the pull force was above the minimum requirement.The event described could not be confirmed as the device performed without any defect noted.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: EB EXC GRN 30IN 5 D/A LR
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13942758
• Report Number: 2210968-2022-02239
• Device Sequence Number: 4524024
• Product Code: GAT
• UDI-Device Identifier: 10705031023307
• UDI-Public: 10705031023307
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: B499T
• Device Catalogue Number: B499T
• Device Lot Number: QKMMMS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown