MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y942H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the suture broke every time any tension was put on it.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: a box with nine unopened samples of product code y942h, lot mek724 were received for analysis.The actual device was not returned for analysis.During the visual inspection of nine unopened samples, no defects were observed on the packets.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were examined along of strand and no defects or damaged were noted.A functional test was performed on the samples and the tensile force met the requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance breakage suture was observed, and the tested sample meet the finished goods requirements.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 3-0 VIO
• 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: 8374529
• Report Number: 2210968-2019-79109
• Device Sequence Number: 16707699
• Product Code: GAN
• UDI-Device Identifier: 10705031059931
• UDI-Public: 10705031059931
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: 04/30/2023
• Device Catalogue Number: Y942H
• Device Lot Number: MEK724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/21/2019
• Patient Sequence Number: 1