MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 27"(70CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR416
Medical Device Problem Codes	Break (1069); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device vr416, lj9dkhe0 number, and no non-conformances related to the reported complaint condition were identified.Attempts are being 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.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the suture was broken when tying.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).It was reported performance breakage suture.An empty opened foil, an empty labeled winding former, a needle and a suture in several pieces of product code vr416, lot lj9dkhe0 were returned for analysis.During the visual inspection of the detached needle, the swage and attachment area the swage and attachment area were noted to be as expected and remnant suture was noted inside the barrel hole.The sutures pieces were examined and have 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 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 performance breakage suture, is suture degradation; due to the improper handling of package.An unopened sample of product code vr416, lot lj9dkhe0 were returned for analysis.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problem 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 sample, no performance - breakage suture was found and the tested sample met the finished goods requirements.

• Brand Name: VICRYL RAPIDE SUTURE 27"(70CM) 3-0 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: 8515764
• Report Number: 2210968-2019-80373
• Device Sequence Number: 14152666
• Product Code: GAM
• UDI-Device Identifier: 10705031134645
• UDI-Public: 10705031134645
• Combination Product (Y/N): N
• PMA/510(K) Number: K033746
• 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): 04/03/2019

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: 01/31/2023
• Device Catalogue Number: VR416
• Device Lot Number: LJ9DKHE0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 06/03/2019
• Patient Sequence Number: 1