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

Catalog Number	3709H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch lmh246, 3709h34 and no non-conformance's 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.
Event or Problem Description
It was reported that the patient underwent a cardiovascular surgery on (b)(6) 2019 and suture was used.The suture was broken during renal artery anastomosis.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).An empty labeled winding former and two needle/sutures pieces of product code 3709, lot # lmh246 were returned for analysis.The product code is double armed.During the visual inspection of the sample, the wage and attachment area of the needles were noted to be as expected.The suture was received broken (cut) in two section appears to be by use of the surgical instrument and no functional test could be performed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause of the breakage suture was an improper handling.

• 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: 9280285
• Report Number: 2210968-2019-89460
• Device Sequence Number: 2145755
• Product Code: GAW
• UDI-Device Identifier: 10705031004641
• UDI-Public: 10705031004641
• 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): 10/09/2019

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: 10/31/2022
• Device Catalogue Number: 3709H
• Device Lot Number: LMH246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/11/2019
• Patient Sequence Number: 1