MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J426H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 a patient underwent a c-section on (b)(6) 2019 and suture was used.During the procedure, the needle popped off at the swage in subcutaneous tissue.The needle was fished out using a bovie.The procedure was completed with a like device with no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 01/31/2020.Additional information: d10, h4, h6.Corrected information: a3, d1, d4.Additional information was requested and the following was obtained: can you clarify the product code and lot for the file? product complaint is for j416h with lot pkm895.A manufacturing record evaluation was performed for the finished device batch pkm895 and no non-conformances were identified.Additional h3 device evaluation summary: it was received for analysis an empty labeled winding former of product code j416, lot pkm895.It was received for analysis an unopened sample of product code j416, lot pkm895.During the visual inspection of the sample, no defects were found on the packet.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand 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 sample, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: VCL CT BRD UD 27IN 3-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9587074
• Report Number: 2210968-2020-00367
• Device Sequence Number: 3337344
• Product Code: GAM
• UDI-Device Identifier: 10705031039773
• UDI-Public: 10705031039773
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• 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
• 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: 08/31/2024
• Device Model Number: J426H
• Device Catalogue Number: J416H
• Device Lot Number: PKM895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 01/31/2020
• Patient Sequence Number: 1