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

Model Number	06/30/2023
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Evaluation: an empty opened foil, a labeled winding former with two detached needles and several sutures piece into tray of product were returned for analysis.This product is double armed.During the visual inspection of the sample, the swage and attachment area were as expected; however, the suture has begun with the process of disintegration; this is the cause of needle pull.Also, the foil was examined for visual inspection and present holes in cavity on the back- foil package due to excessive manipulation and 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.Per the sample condition the assignable cause of suture needle pull off pre-op is a suture degradation; due to the improper handling of package.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a suture was used.During surgery, it was found that the suture had been detached from the needle.It was not a control release needle.There were no adverse patient consequences reported.No additional information was provided.

• 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: 8194523
• Report Number: 2210968-2018-77994
• Device Sequence Number: 13928869
• Product Code: GAN
• UDI-Device Identifier: 10705031059450
• UDI-Public: 10705031059450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/29/2018

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: 05/31/2022
• Device Model Number: 06/30/2023
• Device Catalogue Number: Y527H
• Device Lot Number: LGM259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/24/2018
• Patient Sequence Number: 1