MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 7-0 D/A TG160-8; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J576G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/12/2020.Device evaluation summary: one opened box with six unopened samples of product code j576, lot pck737 were returned for analysis.During the visual inspection of six 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 strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.A manufacturing record evaluation was performed for the finished device pck737 batch number, and no non-conformance's were identified.
Event or Problem Description
It was reported that the patient underwent an unknown eye procedure on (b)(6) 2020 and suture was used.The suture was loaded on the needle driver, passed to the doctor and after suturing, the needle driver was passed to the scrub tech and it was noticed the needle has separated from the suture and fallen away from the patient, on the sterile drape.It was not reported how the procedure was completed.There were no patient consequences reported.

• Brand Name: VCL CT BRD VIO 18IN 7-0 D/A TG160-8
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9702235
• Report Number: 2210968-2020-01150
• Device Sequence Number: 1681164
• Product Code: GAM
• UDI-Device Identifier: 10705031041387
• UDI-Public: 10705031041387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: 02/29/2024
• Device Model Number: J576G
• Device Catalogue Number: J576G
• Device Lot Number: PCK737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1