MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y427H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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 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 via: was there any change in the patient¿s post-operative care, due to the prolonged procedure? no.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no.What tissue was being sutured when the event occurred? unsure as they only realized, the needle tip was missing when the suture was passed back to scrub.Was additional dissection required in other organs/tissues other than the target tissue? no, they found the suture on the patient's chest.Did the needle fall into the patient? if yes, were x-rays taken to locate the needle? no, the scrub found the needle on the patient's chest.Was there any patient consequence or injury? no.What is the patient¿s current health status and condition? good health.Was any other tissue damaged as a result of searching the needle? no.What measures were taken to retrieved the broken piece? stop progression of the surgery.And surgeon assist, and nurses looked for needle.This is the second incident happened in less than a month involving sutures, have the first events been previously reported to ethicon? if so, provide the respective reference number(s).The original complaint was not brought to our attention.Could you please clarify device's availability? unsure.Device return status.Please document the shipment tracking number: device was discarded in or a manufacturing record evaluation was performed for the finished device lot.And no non-conformances were identified.Events reported via: (b)(6), 2210968-2023-04608.
Event or Problem Description
It was reported, that a patient underwent a plastic surgery on (b)(6) 2023.And suture was used.During the procedure, the surgeon used monocryl 3-0 ps2.After handling back, the suture to the scrub, the scrub noticed the sharp end of the suture was missing (few millimeters approximately).The nurse mentioned, it to the surgeon and start searching.Hoping they will find it even though it seems to be impossible, due to the size of it.The scrub nurse found it shortly on patients chest.This suture happened to be the last item from this box/batch.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: MCRYL UD 27IN 3-0 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; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17199978
• Report Number: 2210968-2023-04607
• Device Sequence Number: 6798573
• Product Code: GAN
• UDI-Device Identifier: 10705031059153
• UDI-Public: 10705031059153
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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 Model Number: Y427H
• Device Catalogue Number: Y427H
• Device Lot Number: TBMHRQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown