MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 4-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y214H
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	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported performance pull off suture needle.An empty opened foil, a suture in the winding former with a parked needle and a paper lid were returned for analysis.During the visual inspection of the sample, the swage and attachment area the swage and attachment area were noted to be as expected.The suture could not be dispensed since it has begun with the process of degradation and the time of exposure of suture to the environment could not be determined.The foil was examined and showed multiples wrinkles and holes in cavity on the top and bottom foil package due to excessive manipulation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample, the assignable cause of pull off suture needle, is a suture degradation; due to the improper handling of package.
Event or Problem Description
It was reported that a patient underwent a gastrointestinal anastomosis surgery on (b)(6) 2019 and suture was used.During the procedure, the needle pulled off when sewing.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.

• Brand Name: MCRYL UD 27IN 4-0 S/A RB-1
• 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: 8367114
• Report Number: 2210968-2019-79045
• Device Sequence Number: 2105929
• Product Code: GAN
• UDI-Device Identifier: 10705031058576
• UDI-Public: 10705031058576
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/29/2019

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: 01/31/2019
• Device Catalogue Number: Y214H
• Device Lot Number: HDM045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/25/2019
• Patient Sequence Number: 1