MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 4-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP773D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Investigation summary: it was reported breakage needle.One picture was provided for analysis.Upon visual inspection of the picture, one broken needle and one winding former with seven parks needle of product code (b)(4), lot qamkbt could be observed.However, no conclusion could be reached as to what may have caused the reported incident since the sample was not returned for analysis.A manufacturing record evaluation was performed for the finished device lot qamkbt, and no non-conformances were identified.Attempts have been 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 a patient underwent a radical prostatectomy procedure on (b)(6) 2020; and a suture was used.During the procedure, the needle tip broke when sewing.The broken needle was retrieved immediately.Changed another one to complete the surgery.There were no adverse patient consequences reported.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 9/15/2020.Additional h3 investigation summary: a suture needle was returned for evaluation.A fracture was observed near the tip of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined 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 tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: VCL+ VIO 8X18IN 4-0 S/A SH CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10325833
• Report Number: 2210968-2020-05577
• Device Sequence Number: 2234067
• Product Code: GAM
• UDI-Device Identifier: 10705031055490
• UDI-Public: 10705031055490
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/15/2020

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: 12/31/2024
• Device Model Number: VCP773D
• Device Catalogue Number: VCP773D
• Device Lot Number: QAMKBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 09/15/2020
• Patient Sequence Number: 1