MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 27IN 4-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP304H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number (b)(4), and no non-conformances were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The suture was detached from a needle when it was opened.There were no adverse patient consequences reported.Upon evaluation of the returned device, it was observed that needle was broken in the swage area.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/11/2020.H3 evaluation: one empty labeled winding former, a detached needle and one dispensed suture of product were received for analysis.During the visual inspection of the sample, it was observed that the needle was broken in the swage area and an additional evaluation is necessary to determine the failure mode.The failed suture needle was submitted for fractographic evaluation to assess the fracture mode of the failure.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A microscope 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 the sample revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.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: MCRYL+ VIO 27IN 4-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9590717
• Report Number: 2210968-2020-00384
• Device Sequence Number: 10885503
• Product Code: GAM
• UDI-Device Identifier: 10705031046344
• UDI-Public: 10705031046344
• Combination Product (Y/N): N
• PMA/510(K) Number: K050845
• 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): 12/19/2019

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: 04/30/2021
• Device Model Number: MCP304H
• Device Catalogue Number: MCP304H
• Device Lot Number: PEM374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1