MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 18IN 5-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP493G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.The suture was used on skin tissue and was not tied.The suture initially was placed interrupted.The breakage occurred during the second tissue pass.In relation to the needle the breakage occurred approximately six inches.The suture did break in two pieces.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Component code: (b)(4) 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.Additional information was requested, and the following was obtained: was there any adverse consequence associated with the patient? no.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; drainage)? if so, please specify.Had to open a new suture to continue closing the skin.Could you tell me if there was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.No.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name: (b)(4), active ingredient(s): triclosan, dosage form: suture/solid/parenteral, strength: 2360 g/m.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 18IN 5-0 S/A P-3 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; 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: 14089348
• Report Number: 2210968-2022-02636
• Device Sequence Number: 14698664
• Product Code: GAM
• UDI-Device Identifier: 10705031046566
• UDI-Public: 10705031046566
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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: 06/30/2023
• Device Model Number: MCP493G
• Device Catalogue Number: MCP493G
• Device Lot Number: RHMKSK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown