MAUDE Adverse Event Report: ETHICON INC. PRONOVA SUTURE 30"(75CM) 6-0 BLU; SUTURE, NON ABSORBABLE, SYNTHETIC

Model Number	M3709
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 cardiovascular procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture detached from the needle during use.It was not a control release needle.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Summary: it was reported performance pull off - suture needle.An opened straight pack folder with a strand double armed, two detached needles and a suture of product.The product code is multistrand count and each folder contains four strands double armed.During the visual inspection of two detached needles, the swage and attachment area were noted to be as expected.The barrel hole of the needles were examined and no suture remnant was noted.The suture was examined and there isn¿t enough impression at the swage ends, resulting in a detached needle from suture.In addition, marks and damaged near of the suture end caused appears to be by use of a surgical instrument could be observed.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.The manufacturing records couldn't be reviewed as the batch number is unknown.According to visual inspection of the sample received, the assignable cause of the performance pull off - suture needle was caused by light swage.This defect is caused when does not tightens the press correctly and the swage area be weak on the needle/suture rep sample: it was received for analysis an opened straight pack with a undispensed needle-suture combination of product.The product code is multi-strand and required four strands double armed per packet.During the visual inspection of the sample, 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 using an instron and the pull force were above the minimum requirements.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Per the condition of the sample, no performance pull off - suture needle was found, and the tested sample met the finished goods requirements.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PRONOVA SUTURE 30"(75CM) 6-0 BLU
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10256926
• Report Number: 2210968-2020-05198
• Device Sequence Number: 2603065
• Product Code: GAW
• UDI-Device Identifier: 10705031045149
• UDI-Public: 10705031045149
• 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): 06/29/2020

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 Model Number: M3709
• Device Catalogue Number: M3709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1