MAUDE Adverse Event Report: ETHICON INC. MONOCRYL POLIGLECAPRONE 25 SUTURE; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y942H
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that an canine underwent an ovariectomy procedure on an unknown date and suture was used.The needle detached at swage after one passage through tissue.Had to open another packet to complete procedure.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Device evaluation summary: an empty opened foil, an empty winding former, a paper lid, a suture and detached needle of product code (b)(4), lot llm999 were returned for analysis.During the visual inspection of the needle the swage and attachment area were as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined and the insertion end was measured and did not meet the requirement.Per the sample condition, the assignable cause of the performance pull off suture needle is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.The reported complaint was confirmed.

• Brand Name: MONOCRYL POLIGLECAPRONE 25 SUTURE
• 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: 7717659
• Report Number: 2210968-2018-74604
• Device Sequence Number: 1452146
• Product Code: GAN
• UDI-Device Identifier: 10705031059931
• UDI-Public: 10705031059931
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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: 09/30/2022
• Device Catalogue Number: Y942H
• Device Lot Number: LLM999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/28/2018
• Patient Sequence Number: 1