MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 6-0 D/A S-28; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J562G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device pem725 batch number, and no non-conformance's were identified.Device evaluation summary: nine unopened samples of product code j562, lot # pem725 were received for evaluation.During the visual inspection of nine unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.No needle breakage was observed.The sutures were dispensed without problems and examined along of the strand and no defects were observed.Also, the samples were tested by resistance test to needle and met the requirements.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the conditions of the sample received, no performance breakage needle were found.
Event or Problem Description
It was reported that a patient underwent an eye lid lift procedure on (b)(6) 2019 and suture was used.While suturing the eye lid the tip of the needle broke off.It did not fall in to the patients eye and it was retrieved.The procedure was completed with a like device with no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A suture needle was returned for evaluation.A fracture was observed at the suture attachment of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.This was a ductile fracture.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.

• Brand Name: VCL CT BRD VIO 18IN 6-0 D/A S-28
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9344079
• Report Number: 2210968-2019-90104
• Device Sequence Number: 16827760
• Product Code: GAM
• UDI-Device Identifier: 10705031041257
• UDI-Public: 10705031041257
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: 04/30/2024
• Device Catalogue Number: J562G
• Device Lot Number: PEM725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/10/2019
• Patient Sequence Number: 1