MAUDE Adverse Event Report: ETHICON INC. GUT PLAIN SUTURE 27"(70CM) 2-0 UND; SUTURE, ABSORBABLE, NATURAL

Catalog Number	853H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2017
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.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 that the patient underwent a c-section procedure on (b)(6) 2017, and suture was used.During the procedure, the suture broke when closing fat layer.There was a five minutes delay to procedure.Another like suture was used to complete the procedure.There were no patient consequences.No additional information is available.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: (b)(4) 2018.An opened sample was sent for analysis.During the visual inspection of the representative sample, no defects were found on the package.The sample was opened and the swage and attachment area of the needle were as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.The needle-suture combination was tested by knot tensile strength and the results is above the minimum individual strength requirement.Per the condition of the representative sample, no performance - breakage suture was found on the strand and the tested suture met the finished goods requirements.

• Brand Name: GUT PLAIN SUTURE 27"(70CM) 2-0 UND
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7244367
• Report Number: 2210968-2018-70695
• Device Sequence Number: 1174198
• Product Code: GAL
• UDI-Device Identifier: 10705031016835
• UDI-Public: 10705031016835
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/09/2018

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: 12/31/2021
• Device Catalogue Number: 853H
• Device Lot Number: LAZ873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1