MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 3-0 S/A CT-3; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP327H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device khz417 number, and no non-conformance's were identified.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 total knee arthroplasty on (b)(6) 2019 and suture was used.The suture was broken easily during interrupted suturing.The surgeon stopped using the product, and a like device from the same lot was used with no problem.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 08/22/2019.Additional h3 investigation summary: it was received for analysis an empty opened foil, a paper lid, an empty winding former and a suture piece of product code vcp327, lot khz417.During the visual inspection of the suture piece, body fluids were noted along of strand.Also, an end of the suture was busted (damaged) while the other extreme was cut that appear to be by the use of a surgical instrument.In addition, the other section of the suture was not returned for analysis.No functional test could be performed due to condition of the sample received.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, the assignable cause of the breakage suture, suggest an improper handling.Additional h3 investigation summary: it was received for analysis five unopened samples of product code vcp327, lot khz417.During the visual inspection of the samples, no defects were found on the package.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 breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: VCL+ VIO 27IN 3-0 S/A CT-3
• 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: 8758379
• Report Number: 2210968-2019-83642
• Device Sequence Number: 13838277
• Product Code: GAM
• UDI-Device Identifier: 10705031052314
• UDI-Public: 10705031052314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032420
• 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): 06/11/2019

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: 06/30/2021
• Device Catalogue Number: VCP327H
• Device Lot Number: KHZ417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/22/2019
• Patient Sequence Number: 1