MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 G/W; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	PXX52
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional summary: it was reported performance pull off suture needle.An opened folder with five parked needle/suture combinations of were received for analysis.This product code contains ten strands double armed per packet.During the visual inspection of opened samples, the swage and attachment area of five double armed needles were noted to be as expected.Sutures were dispensed without problems and examined along of the strand and no defects, or damaged 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 conditions of the samples received, no performance pull off suture needle were found, and the tested samples met the finished goods requirements.An unopened sample was received for analysis.This product code contains ten strands double armed per packet.During the visual inspection of unopened sample, no defects were found on the package.The sample was opened and the swage and attachment area of ten double armed needles were noted to be as expected.Sutures were dispensed without problems and examined along of the strands and no defects, or damaged 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 conditions of the sample received, no performance pull off suture needle were found, and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 3 device issues captured in reports (b)(4).Analysis results have been included in follow-up reports for each.Additional information was requested and the following was obtained: please provide clarification 'the green strands were coming apart.Were the needles found already separated from the suture threads upon opening the package? or were the sutures found broken in the package? or please provide specific device issue.Answer: a total of 3 packets were opened from this lot # mc5180, all of which had green strands coming apart.The suture was intact in the packaging, but came apart once a bite of tissue had been taken.Another lot # of pxx52 was found and the suture performed well.
Event or Problem Description
It was reported that a patient underwent a bental procedure on (b)(6) 2018, and suture was used.During the procedure, the green strands were coming apart.Another like device with a different lot number was used to complete the procedure.There were no consequences for the patient.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 G/W
• 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: 8024841
• Report Number: 2210968-2018-76837
• Device Sequence Number: 16486003
• Product Code: GAT
• UDI-Device Identifier: 10705031049338
• UDI-Public: 10705031049338
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

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 Expiration Date: 02/28/2023
• Device Catalogue Number: PXX52
• Device Lot Number: MC5180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/31/2018
• Patient Sequence Number: 1