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

Model Number	Y358H
Medical Device Problem Codes	Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch number lhz809, and no non-conformances were identified.Investigation summary: it was received for analysis an open sample of product code y358h, lot lhz809.During the visual inspection of sample, the swage and attachment area of the needle were noted to be as expected, suture remnant was noted at the barrel hole.The suture could not be dispensed since have begun with the process of degradation and this caused that the needle was detached of the suture.The functional test cannot be performed.The foil present excessive handling and multiples wrinkles and holes were noted.This condition contributed to degradation of the suture.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to visual inspection the assignable cause of pull off suture needle, was caused by suture degradation exposure to environment.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were there any adverse patient consequences?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle thread separation after opening the outer package.There were no adverse patient consequences reported.Upon evaluation of the returned device, the foil presented excessive handling and multiples wrinkles and holes were noted.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/29/2020.Additional information was requested and the following was obtained: were there any adverse patient consequences? no patient consequence.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10135899
• Report Number: 2210968-2020-04433
• Device Sequence Number: 3732143
• Product Code: GAN
• UDI-Device Identifier: 10705031059023
• UDI-Public: 10705031059023
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K960653
• 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): 06/03/2020

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 Model Number: Y358H
• Device Catalogue Number: Y358H
• Device Lot Number: LHZ809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1