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

Catalog Number	683G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that a patient underwent an implant placement in the mouth on (b)(6) 2018 and suture was used.During the procedure, the suture separated from the needle.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 12/7/2018.Additional evaluation summary: there was no sample received for analysis.Only a picture of the sample was received for analysis.Upon visual inspection of the picture, a needle detached from suture, a folder and a paper cover could be observed.However, no conclusion could be reached as how this happen as the device was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• 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 NJ 08876 0151
• MDR Report Key: 7930035
• Report Number: 2210968-2018-76257
• Device Sequence Number: 11241443
• Product Code: GAP
• UDI-Device Identifier: 10705031008175
• UDI-Public: 10705031008175
• 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,Followup
• Report Date (Section B): 09/10/2018

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: 04/30/2023
• Device Catalogue Number: 683G
• Device Lot Number: MEP849
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 11/26/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/18/2018; 12/07/2018
• Patient Sequence Number: 1
• Patient Age: 37 YR