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

Model Number	Y417H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).(b)(4).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.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.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.How long (in minutes) did the surgery prolong? unknown.Please provide the lot number not provided by the rn reporter.Package thrown away.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.This medwatch report is in response to receipt of a voluntary medwatch report:: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cesarean section procedure on (b)(6) 2022 and suture was used.During the procedure, upon closure, needle broke free from suture, time spent looking for needle, x-ray called, multiple x-rays taken, suture found and counts rectified.There were no patient consequences reported.Additional information was requested.

• Brand Name: MCRYL UD 27IN 2-0 S/A SH MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14360141
• Report Number: 2210968-2022-03593
• Device Sequence Number: 4921603
• Product Code: GAN
• UDI-Device Identifier: 10705031059139
• UDI-Public: 10705031059139
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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 Model Number: Y417H
• Device Catalogue Number: Y417H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 27 YR
• Patient Sex: Female