MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 2-0 S/A FS; SUTURE, NONABSORBABLE, SILK

Catalog Number	685H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 and dental procedure on (b)(6) 2019 and suture was used.During use the needle broke off.The needle was retrieved and another suture was used.No patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional evaluation summary: the actual sample was returned for evaluation.During the visual inspection of the sample, it was observed that needle was broken in the swage area.Also, there are slight marks on the body needle.The suture was examined for visual inspection defects and there was a needle piece attached in the suture.A fracture was observed at the suture attachment of the needle.The fracture surfaces were examined 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 BLK 18IN 2-0 S/A FS
• 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: 8475761
• Report Number: 2210968-2019-79919
• Device Sequence Number: 1919963
• Product Code: GAP
• UDI-Device Identifier: 10705031008236
• UDI-Public: 10705031008236
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 685H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1