MAUDE Adverse Event Report: ETHICON INC. PRONOVA SUTURE 36"(90CM) 4-0 BLU; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	3521H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the patient underwent an unknown cardiovascular procedure on (b)(6) 2019 and suture was used.The needle was detached from the suture during vascular anastomosis by continuous suturing.It was not a control release needle.No additional information was provided.There were no patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 07/26/2019.H3 device evaluation summary: it was received for analysis a paper lid, an empty winding former and two detached needles of product code 3521, lot mjh549.This product code is double armed.During the visual inspection of the needles, the swage and attachment area were as expected, and remnant of the suture was noted into the barrel holes and slightly marks were observed on the edge of the needle that appears to be by the use of a surgical instrument.The suture was not received for evaluation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to needle condition, the assignable cause of the performance pull off suture needle was an improper handling.To avoid this kind of damage, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.A manufacturing record evaluation was performed for the finished device batch mjh549 and no non-conformances were identified.

• Brand Name: PRONOVA SUTURE 36"(90CM) 4-0 BLU
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8703856
• Report Number: 2210968-2019-82796
• Device Sequence Number: 14020254
• Product Code: GAW
• UDI-Device Identifier: 10705031004443
• UDI-Public: 10705031004443
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001625
• 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): 05/21/2019

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: 07/31/2023
• Device Catalogue Number: 3521H
• Device Lot Number: MJH549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1