MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 36IN 1 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP347H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional information was requested, and the following was obtained: was there any additional tissue damage as a result of searching for the needle piece? no, nothing reported.Was there any change in the patient¿s post-operative care due to the prolonged procedure? no, nothing reported.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no, nothing reported.How long (in minutes) did the surgery prolong? not reported.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 thread break into two pieces? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 ¿g/m.Information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a c-section procedure on (b)(6) 2022 and suture was used.Suture material used for the caesarean section broke during the procedure.The needle broke and some part of it was left inside the uterus but was retrieved before closing the sheath.The radiographer was not required as per surgeons¿ instruction broken parts measured together for completeness.The procedure was delayed for an unspecified amount of time, and was successfully completed.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/6/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Additional information requested, the following was obtained: "no the suture didn¿t break it was the needle".H3 investigational summary: a failed suture needle was submitted fractographic evaluation.The component was identified as product code mcp347h.It was requested that assess the fracture mode of the failure.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ¿g/m.

• Brand Name: MCRYL+ VIO 36IN 1 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14106811
• Report Number: 2210968-2022-02674
• Device Sequence Number: 6284932
• Product Code: GAM
• UDI-Device Identifier: 10705031046443
• UDI-Public: 10705031046443
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 05/06/2022

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: 04/30/2023
• Device Model Number: MCP347H
• Device Catalogue Number: MCP347H
• Device Lot Number: REMMMC
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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