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.Sixteen unopened samples of product code y214, lot hj6032 were returned for analysis.In the visual inspection of sixteen unopened samples, delamination, wrinkles and holes in cavity on the top and bottom foil package due to excessive manipulation were noted.The samples were opened, and the swage and attachment area were noted to be as expected.However, due to condition of the packets the sutures have begun with the process of degradation and the time of exposure of suture to the environment could not be determined.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the open sample and representative samples, the assignable cause of performance pull off suture needle, is a suture degradation; due to the improper handling of package.Additional information was requested and the following was obtained: confirm the total qty involved? is it 1 or 17? 17, the surgeon found needle pull-off issues for 4 packages continuously in one operation.And refused to using the rest ones.Representative samples returned to support investigation of 4 device issues captured in reports 2210968-2019-79041, 2210968-2019-79419, 2210968-2019-79421.Analysis results have been included in reports for each.
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.Additional information has been requested.

• 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: 8414539
• Report Number: 2210968-2019-79420
• Device Sequence Number: 1796008
• 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): 02/28/2019

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: 07/31/2019
• Device Catalogue Number: Y214H
• Device Lot Number: HJ6032
• 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: 02/28/2019
• Initial Report FDA Received Date: 03/12/2019
• Patient Sequence Number: 1