MAUDE Adverse Event Report: ETHICON INC. PRONOVA* BLUE MONO; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	D10114
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch mmh592- d10114 and no non-conformances were identified.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 additional information was obtained: can you confirm and provide the specific number of devices (total qty actually involved with reported issue) that failed during use on same patient/ single procedure ? it is reported 3 devices.Note: events reported via mw 2210968-2019-87143, 2210968-2019-87144.
Event or Problem Description
It was reported that the patient underwent an unknown cardiovascular surgery on (b)(6) 2019 and suture was used.During the procedure, the needle was detached from the suture during continuous suturing.It was not a control release needle.Another product in another lot number was used with no problem.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/10/2019.H3 device evaluation summary: it was received for analysis eighty unopened samples of product code d10114, lot mmh592.The complaint sample was not received for evaluation.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands 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 samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 3 device issues captured in reports 2210968-2019-87143 and 2210968-2019-87144.Analysis results have been included in follow up reports for each.

• 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: 9007662
• Report Number: 2210968-2019-87145
• Device Sequence Number: 2752910
• Product Code: GAW
• UDI-Device Identifier: 10705031203396
• UDI-Public: 10705031203396
• 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): 08/16/2019

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: D10114
• Device Lot Number: MMH592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1