MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 18IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP496G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
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.H3 investigation summary: the product was returned to ethicon.One needle suture piece outside its foil packet was received for analysis.Product code mcp496.Upon initial inspection of the returned sample, no issues related to breakage sutures were found.However, it was noted that the end suture was noted to be cut probably caused by a surgical instrument.In addition, body fluids were observed on the strand.The other section of the suture was not returned for analysis.The product code mcp496 contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.Per the condition of the returned sample, no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: as with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional device analysis: the product was returned to ethicon.One needle suture piece outside its foil packet was received for analysis.Product code mcp496.Upon initial inspection of the returned sample, no issues related to breakage sutures were found.However, it was noted that the end suture was noted to be cut probably caused by a surgical instrument.In addition, body fluids were observed on the strand.The other section of the suture was not returned for analysis.The product code mcp496 contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.Per the condition of the returned sample, no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: as with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.
Event or Problem Description
It was reported that a patient underwent a c- section procedure on (b)(6) 2024 and suture was used.During the procedure, during the operation, it was reported that the suture was broken when the surgeon attempted to sew the tissue.Changed another one to use, the problem of pulling off suture needle had happened in the newly dispensed suture when it was opened to prepare for surgery.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: MCRYL+ UD 18IN 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: 20632657
• Report Number: 2210968-2024-11631
• Device Sequence Number: 8039022
• Product Code: GAM
• UDI-Device Identifier: 10705031046597
• UDI-Public: (01)10705031046597(17)260531(10)101T70
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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: 05/31/2026
• Device Catalogue Number: MCP496G
• Device Lot Number: 101T70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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