MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE; SUTURE, NONABSORBABLE, SILK

Catalog Number	685G
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
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.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 during a procedure on (b)(6) 2018 a suture was used.While pulling the suture through the tissue the needle came off the suture and fell into the patient.After 30 to 45 minutes the needle was recovered.Another like device was used to complete the procedure.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
Product complaint # = > pc-000211616 date sent to the fda: 08/10/2018 device evaluation summary: an unopened sample of product code 685, lot leh857 was returned for analysis.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the swage and attachment area were as expected.The suture was dispensed without problems and examined along of the strand and no defects were observed.A functional test was performed, and the pull force were above the minimum requirements.Per the conditions of the sample received, no attachment defects were found and the tested sample met the finished goods requirements.A used needle was returned for analysis.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.The fracture surfaces were examined microscopically in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.

• Brand Name: SILK SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7671270
• Report Number: 2210968-2018-74189
• Device Sequence Number: 920839
• Product Code: GAP
• UDI-Device Identifier: 10705031008229
• UDI-Public: 10705031008229
• Combination Product (Y/N): N
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 04/30/2022
• Device Catalogue Number: 685G
• Device Lot Number: LEH857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/10/2018
• Patient Sequence Number: 1