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	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.
Event or Problem Description
It was reported a patient underwent a hemicolectomy on (b)(6) 2018 and suture was used.Needle separated from suture during tissue passage.Surgery completed as planned with new suture.No adverse patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 02/20/2019.Investigation summary: it was reported performance pull off suture needle.An empty labeled winding formed and a detached needle were received for evaluation.During the visual inspection of detached needle, the swage and attachment area were noted to be as expected and no suture remnant was noted into the barrel hole.Body fluids and slightly marks were noted on body needle that appear to be by use of a surgical instrument, the suture was not received for evaluation to determine the assignable cause.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to needle condition and that the suture was not received for evaluation, it could not be determined what may have caused the reported incident of: ¿needle separated from suture during tissue passage.

• 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: 8169253
• Report Number: 2210968-2018-77809
• Device Sequence Number: 1684373
• Product Code: GAN
• UDI-Device Identifier: 10705031059115
• UDI-Public: 10705031059115
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K964072
• 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
• Report Date (Section B): 11/21/2018

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: 02/28/2023
• Device Catalogue Number: Y415H
• Device Lot Number: MCM263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 02/20/2019
• Patient Sequence Number: 1