MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 4-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y315H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified evaluation: an empty opened box, a detached needle, a dispensed suture and five unopened samples of product were returned for analysis.During the visual inspection of sample, the swage and attachment area were as expected.The barrel hole was examined under magnification for suture remnant and none was noted.Additionally, there were slight marks on body that appeared to be by use of surgical instrument.The suture end was examined and there wasn¿t sufficient impression at the swage end, resulting in the needle pull off.In the visual inspection of five unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area noted to be as expected.The sutures were dispensed without problems and examined along the strands with no defects or damages found.A functional test was performed and the pull force was above the minimum 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 opened sample, the assignable cause of the damaged product is a light swage defect.This defect is caused when the press is not tightened correctly and causes the swage area to weaken on the needle/suture.Per the conditions of the five representatives samples, no attachment defects were found, and the tested sample met the finished goods requirements.
Event or Problem Description
It was reported that an animal underwent an unknown animal surgery procedure on (b)(6) 2019 and a suture was used.During surgery, the needle separated from the suture as the doctor was applying the needle to subcutaneous tissue.A replacement device was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 4-0 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: 8344904
• Report Number: 2210968-2019-78917
• Device Sequence Number: 16748786
• Product Code: GAN
• UDI-Device Identifier: 10705031058729
• UDI-Public: 10705031058729
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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: 06/30/2022
• Device Catalogue Number: Y315H
• Device Lot Number: LHZ525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/15/2019
• Patient Sequence Number: 1