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

Catalog Number	Y936H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.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.Event: detachment of the needle.Were there patient consequences? if yes, please specify.Please provide lot number.When did the needle detach or pull off from the suture (in the package, during removal from the package, during handling prior to using on the patient, or during use on the patient)? please provide the name of procedure.Event date: please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Please confirm if the devices are available for product return.If yes, please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.The manufacturing records could not be reviewed as the batch/lot number is unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in (b)(6) 2024 and suture was used.During the procedure, detachment of the needle.There were no adverse consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/25/2024.H6 component code: g07002 no device problem found.H6 component code: c22 - photo analysis.H3 investigational summary: the product was returned to ethicon for evaluation.One detached needle and one winding former with a suture in several pieces were received for analysis.Upon visual assessment of the returned sample, it was noted that the needle was detached from the suture.The swage and attachment area were noted as expected; the barrel hole was examined under magnification and remnant suture was observed.The suture could not be dispensed since have begun with the process of degradation and the time of exposure of sutures to the environment could not be determined.In addition, six photos were provided, and they showed different gut products and one monocryl product.Per the conditions of the returned sample, no conclusion could be reached as to what caused the reported complaint.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 will be conducted through complaint trending as part of post-market surveillance.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: MCRYL UD 27IN 3-0 S/A PS-1 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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 ; 9083863534
• MDR Report Key: 20473347
• Report Number: 2210968-2024-10823
• Device Sequence Number: 7613120
• Product Code: GAN
• UDI-Device Identifier: 10705031059917
• UDI-Public: 10705031059917
• Combination Product (Y/N): N
• Initial Reporter Country: HO
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: Y936H
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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