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

Model Number	Y434H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.The following information was requested, but unavailable: pcf reply: what was the initial procedure? unknown.What was used to complete the procedure? another pack of suture(same code) what is the event day and procedure date? unknown.What is the lot number? unknown.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2020 and suture was used.During the procedure, the suture got detached from the needle.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/12/2021.  additional information: d4, d9, g1, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.  additional information was requested and the following was obtained: what was the initial procedure? unknown.What was used to complete the procedure? another pack of suture (same code).What is the event day and procedure date? unknown.What is the lot number? unknown.H3 evaluation: an opened sample of product was received for evaluation.During the visual inspection of the needle, the swage and attachment area were noted to be as expected, the edge of the barrel hole could be observed with marks that appears to be by use of the surgical instrument.The end of the suture was noted with damage caused by use of a surgical instrument.The condition of the sample received indicate an improper handling of the device.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.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, 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.

• Brand Name: MCRYL UD 27IN 4-0 S/A TF
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11014020
• Report Number: 2210968-2020-09945
• Device Sequence Number: 14351086
• Product Code: GAN
• UDI-Device Identifier: 10705031059191
• UDI-Public: 10705031059191
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020

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: 03/31/2025
• Device Model Number: Y434H
• Device Catalogue Number: Y434H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 02/12/2021
• Patient Sequence Number: 1