MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 4X36IN 3-0 D/A SH-1; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D9844
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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.The following information was requested but unavailable: were there any unexpected outcomes or complications as a result of the prolonged surgery time? was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain.
Event or Problem Description
It was reported that patient underwent abdominal aortic aneurysm replacement surgery on (b)(6) 2019 and suture was used.The needle detached during vascular anastomosis by continuous suturing.It was not a control release needle.The operation time was extended within 30 minutes.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 08/26/2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional h3: it was reported performance pull off suture needle.Four unopened samples were returned for analysis.The product code is multistrand count and each packet contains four strands double armed.During the visual inspection of four samples, no defects were found on the packages.The samples were opened, and each packet contains four strands double armed.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, or damaged 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 conditions of the samples received, performance pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: PRLNE HS BLU 4X36IN 3-0 D/A SH-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8809883
• Report Number: 2210968-2019-84503
• Device Sequence Number: 2693678
• Product Code: GAW
• UDI-Device Identifier: 10705031035225
• UDI-Public: 10705031035225
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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): 06/25/2019

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: 10/31/2023
• Device Catalogue Number: D9844
• Device Lot Number: MMH924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/20/2019
• Supplement Report FDA Received Date: 08/26/2019
• Patient Sequence Number: 1