MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 1 S/A OS-6; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J535H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture broke off from the needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Additional information was requested, and the following was obtained: please provide procedure name and date- #1 vicryl stock #j535 exp date is 6/30/2026 lot # rhmbqu.It is stated: the suture is breaking off from the needle constantly.Please confirm how many sutures separated from the needle during suturing on this one patient during this single surgical procedure? 4 sutures on this patient, has been happening on multiple patients.2 on the patient before, 2 on the patient before that.8 total today alone.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail in cost only, have to open additional sutures, the cost in surgical time for redoing the suture, and the aggravation of the surgeon.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the procedure name and date for the second and third patient event? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/13/2022 h6 component code: g07002 no device problem found a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: (b)(4) packets of product code j535h were returned to ethicon for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the packets.As per sampling plan visual inspection were performed to thirteen packets, the samples were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand to detect any issue on the suture and no defects were observed during evaluation.Functional test was performed, and the pull force results were above the minimum requirements.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.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.Additional information was requested, the following was received: the dates are (b)(6), (b)(6) , all were on total knees and happened intraoperatively.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.Related reports: 2210968-2022-03755, 2210968-2022-03756, and 2210968-2022-03757.

• Brand Name: VCL CT BRD UD 27IN 1 S/A OS-6
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14416705
• Report Number: 2210968-2022-03754
• Device Sequence Number: 20202269
• Product Code: GAM
• UDI-Device Identifier: 10705031041042
• UDI-Public: 10705031041042
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 06/30/2026
• Device Model Number: J535H
• Device Catalogue Number: J535H
• Device Lot Number: RHMBQU
• 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: 04/18/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown