MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP426H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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, 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H6 component code: g07002 device not returned 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.Did the suture break or did the suture separated from the needle? when did the issue occur (during removal from package, during handling prior to use on patient, or during use on the patient)? please specify was the needle piece removed from the patient during the same procedure? quantity involved is four (4); however, the event description mentions only one product.Please clarify, did the same issue occur with all four sutures involved? if no, please clarify what was the quality issue experienced with each involved suture.Are the products available to be returned for evaluation? additional information was requested, and the following was obtained: as per our checking, the reported product was already disposed of during the case as per hospital policy.
Event or Problem Description
It was reported that a patient underwent an excision of breast mass procedure on (b)(6) 2023 and suture was used.During the procedure, as the surgeon was about to close the excision, the suture suddenly snapped leaving the needle in the skin.Any surgical delay was unknown.There were no patient consequences reported.Additional information was requested.

• Brand Name: MCRYL+ UD 27IN 4-0 S/A PS-2 PRM MP
• 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: 20245340
• Report Number: 2210968-2024-09906
• Device Sequence Number: 7312208
• Product Code: GAM
• UDI-Device Identifier: 10705031046504
• UDI-Public: (01)10705031046504(17)240831(10)SKMMHA
• Combination Product (Y/N): Y
• Initial Reporter Country: RP
• PMA/510(K) Number: K050845
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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 Expiration Date: 08/31/2024
• Device Catalogue Number: MCP426H
• Device Lot Number: SKMMHA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown