MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 4-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y214H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a prostatectomy on (b)(6) 2021 and the suture was used.During surgery, the suture separated from the needle without using much force.No parts fell into the situs and there was no delay in surgery.A like device was used to complete the surgery.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.Additional information was requested and the following was obtained: were there any patient consequences? customer confirmed that the issue did not have any consequences for the patient.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.Events reported in 2210968-2021-12508, 2210968-2021-12509, 2210968-2021-12510, 2210968-2021-12511, 2210968-2021-12513, 2210968-2021-12514, 2210968-2021-12515, 2210968-2021-12516, 2210968-2021-12517, and 2210968-2021-12518.

• Brand Name: MCRYL UD 27IN 4-0 S/A RB-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: 12981784
• Report Number: 2210968-2021-12512
• Device Sequence Number: 4216892
• Product Code: GAN
• UDI-Device Identifier: 10705031058576
• UDI-Public: 10705031058576
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 09/30/2025
• Device Model Number: Y214H
• Device Catalogue Number: Y214H
• Device Lot Number: QLMJTD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male