MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 4-0 S/A PS-1 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP935H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot (pc2366), and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the name of the initial procedure? in event description indicates "the needle is popping off sutures mid procedure" could you please confirm if the issue occurred-intra op? could you please provide event day and procedure date? was the surgery delayed due to the issue? was the surgery completed successfully? could you please inform if there any patient consequence or injury? could you please confirm how many devices were involved in the reported issue? what is the correct lot numbers? device return follow up.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 an unknown procedure on an unknown date and a suture was used.During the procedure, the needle separated from the suture mid procedure.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 05/06/2020.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/12/2020.Additional h3 investigation summary: one open box with unopened samples of product code vcp435, lot pc2366 was returned for analysis.The complaint sample was not received for evaluation.During the visual inspection of 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.

• Brand Name: VCL+ UD 27IN 4-0 S/A PS-1 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10011383
• Report Number: 2210968-2020-03560
• Device Sequence Number: 16842602
• Product Code: GAM
• UDI-Device Identifier: 10705031056060
• UDI-Public: 10705031056060
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2020

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: VCP935H
• Device Catalogue Number: VCP935H
• Device Lot Number: PC2366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 05/05/2020; 05/07/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/06/2020; 05/12/2020
• Patient Sequence Number: 1