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

Catalog Number	Y415H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being 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.
Event or Problem Description
It was reported that the patient underwent gastrectomy on (b)(6) 2019 and suture was used.During the procedure, the needle separated from suture during tissue passage.The surgery was completed with new suture.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: the actual device was received for evaluation as a detached needle and a suture piece.During the visual inspection of a detached needle, the swage and attachment area were noted to be as expected and no suture remnant was noted into the barrel hole.The suture piece was examined, and present body fluids and the impression of the swage area was not observed due to the ends suture were cut appears to be by the use of a surgical instrument.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: the actual device was received for analysis as a detached needle and a suture piece of product code y415.During the visual inspection of the detached needle, the swage and attachment area were as expect, however no suture remnant at the barrel of the hole were observed.In addition, the suture piece returned for review is the tail of the sample with a length of 43 cm with body fluids and the end cut appears to be by the use of a surgical instrument.When handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to the application of surgical instruments such as forceps or needle holders.According to the sample condition, we are unable to determine the cause as the suture was not returned complete.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: MCRYL UD 27IN 4-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8362768
• Report Number: 2210968-2019-79010
• Device Sequence Number: 2105762
• Product Code: GAN
• UDI-Device Identifier: 10705031059115
• UDI-Public: 10705031059115
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2019

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: 07/31/2023
• Device Catalogue Number: Y415H
• Device Lot Number: MJM979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/08/2019; 03/25/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/20/2019; 03/27/2019
• Patient Sequence Number: 1