MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 3-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y215H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
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.During the procedure, the suture thread broke, no excessive forced was used.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/21/2024.H6 component code: g07002 - device not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: *device follow up.The following information was reported: was surgery delayed due to the reported event? --> unknown, was procedure successfully completed? --> unknown, were fragments generated? --> unknown, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown.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.
Additional Manufacturer Narrative
(b)(4).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.Additional information: d9, h3, h6.Additional h6 component code: g07002 no device problem found.Additional h3 investigation summary: the product was returned to ethicon for evaluation.Visual analysis of the returned sample determined that one unopened sample that pertain to product code y215h was received for evaluation.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.As part of the 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: MCRYL UD 27IN 3-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18748146
• Report Number: 2210968-2024-01604
• Device Sequence Number: 3703495
• Product Code: GAN
• UDI-Device Identifier: 10705031058583
• UDI-Public: 10705031058583
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K964072
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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 Catalogue Number: Y215H
• Device Lot Number: SJMTRD
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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