MAUDE Adverse Event Report: ETHICON INC. EB EXC 4GRN/4WHT 30IN 2-0 DA RB-1 8PLGT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	PXX41
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 a patient underwent an unknown cardiovascular surgery on an unknown date and suture was used.The suture was broken during continuous suturing.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/11/2019.An opened folder with two parked needle/suture combinations (a white and a green) and a dispensed needle/suture combination (white) of product code pxx41 were returned for analysis.This product code is double armed and require eight strands per packet (four green and four white).During the visual inspection of the three needle-suture combinations, the swage and attachment area of needles were as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed using a instron and the tensile force were above the minimum requirements.Per the condition of the representative samples, breakage suture was found on the sutures and the tested samples met the requirements.

• Brand Name: EB EXC 4GRN/4WHT 30IN 2-0 DA RB-1 8PLGT
• 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: 8151015
• Report Number: 2210968-2018-77669
• Device Sequence Number: 2124934
• Product Code: GAT
• UDI-Device Identifier: 10705031049307
• UDI-Public: 10705031049307
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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): 11/16/2018

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 Catalogue Number: PXX41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/11/2019
• Patient Sequence Number: 1