MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 27"(70CM) 0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J270H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device mm2162 number, and no non-conformances were identified.The following information was requested, but unavailable: lot m2926 is invalid; please provide correct lot number.Did 3 devices, (2 of lot mm2162 and 1 of the other lot) had suture breakage issues in a single procedure?.
Event or Problem Description
It was reported that the patient underwent a gensling, laparoscopic port site procedure on (b)(6) 2019 and suture was used.During closure the suture material broke when attempted to hand tie.No adverse patient consequence reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Sent to the fda: 07/23/2019.H3 evaluation: it was received for analysis an empty opened foil and seven unopened samples of product.During the visual inspection of seven samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: VICRYL SUTURE 27"(70CM) 0 UND
• 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: 8697668
• Report Number: 2210968-2019-82723
• Device Sequence Number: 2005545
• Product Code: GAM
• UDI-Device Identifier: 10705031038455
• UDI-Public: 10705031038455
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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: 10/31/2023
• Device Catalogue Number: J270H
• Device Lot Number: MM2162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1