MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	683G
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
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During use, the suture was broken.There were no adverse consequences to the patient.No additional information is available.
Additional Manufacturer Narrative
Pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional h3 evaluation summary: an unopened sample was returned 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: SILK SUTURE 18"(45CM) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7198587
• Report Number: 2210968-2018-70314
• Device Sequence Number: 19099108
• Product Code: GAP
• UDI-Device Identifier: 10705031008175
• UDI-Public: 10705031008175
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2017

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: 06/30/2021
• Device Catalogue Number: 683G
• Device Lot Number: KHP525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1