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

Catalog Number	Y415H
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that a patient underwent an hernia repair procedure on (b)(6) 2018 and suture was used.Needle pull-off during tissue passage.No patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).An empty opened foil, a detached needle and a dispensed suture of product were returned for analysis.During the visual inspection of needle, the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification and remnant suture were noted.The suture end is severely cut (damaged), resulting in a clip off defect.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of sample received, the assignable cause of the suture needle pull off suture suggests a clip off defect.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.

• 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: 7797338
• Report Number: 2210968-2018-75273
• Device Sequence Number: 1013141
• 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): 07/24/2018

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: 04/30/2023
• Device Catalogue Number: Y415H
• Device Lot Number: ME6484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 01/03/2019
• Patient Sequence Number: 1