MAUDE Adverse Event Report: BRA PDSII VIO 27IN 4-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z315H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot plk644, 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 laparoscopic gastrectomy procedure using hinged double door method on (b)(6) 2020; and a suture was used.During the procedure, the suture pulled off the needle after holding the suture.When putting the needle-suture through the trocar.It was not a control release needle.The needle fell in the body but was retrieved using forceps.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 05/11/2020.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.A opened box with representative samples of product were returned for analysis.During the visual inspection of samples, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand with no defects, or damage observed.A functional test was performed and the pull force was 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 conditions of the samples received, no suture needle pull off was found, and the tested samples met the finished goods requirements.

• Brand Name: PDSII VIO 27IN 4-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): BRA; 12240-908; somerville NJ 08876
• MDR Report Key: 9986882
• Report Number: 2210968-2020-03360
• Device Sequence Number: 4355992
• Product Code: NEW
• UDI-Device Identifier: 10705031060456
• UDI-Public: 10705031060456
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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): 04/06/2020

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: 09/30/2024
• Device Model Number: Z315H
• Device Catalogue Number: Z315H
• Device Lot Number: PLK644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/11/2020
• Patient Sequence Number: 1