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	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.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.Is there evidence that could suggest that the reported suture was part of a product mix in the package? please provide the source or name of person providing answers to follow-up questions.Attempts are being 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H6 component code: g07002 ¿ device not returned.Related events captured via: 2210968-2024-03396, 2210968-2024-03397.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2024, and suture was used.During the procedure, quite a few sutures were opened before noticing a packaging defect.The representative had ordered 3-0 ps-1.The box and suture package were labeled correctly, but the sutures were all coming out a p-3 size.Two boxes were affected.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/1/2024.Additional information was requested, the following was obtained: is there evidence that could suggest that the reported suture was part of a product mix in the package? no.Device return status.Please document the shipment tracking number: not returned as of yet.Still in customer possession.Please provide return info if they need to be shipped back.Please provide the source or name of person providing answers to follow-up questions: (b)(6), surgical tech lead.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 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 Manufacturer Narrative
Product complaint # (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: h6.Photo investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows one opened foil labeled as y936 on top of a product box.In a second photo, there are two boxes and a package with three opened foils inside.Based on the photo review, the event describe is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• 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.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19074184
• Report Number: 2210968-2024-03397
• Device Sequence Number: 6900853
• Product Code: GAN
• UDI-Device Identifier: 10705031059917
• UDI-Public: (01)10705031059917(17)281031(10)TMMDQD
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup

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
• Device Lot Number: TMMDQD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/08/2024; 09/24/2024; 05/12/2025
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/01/2024; 10/24/2024; 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3006638824-10/08/24-001-
• Patient Sequence Number: 1
• Patient Sex: Unknown