MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	K832H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary: it was reported performance pull off suture needle.Two paper lid and two winding former with a suture each of product code (b)(4), lot lkr974 were returned for analysis.During the visual inspection of two samples, the suture were dispensed without problem and the insertion did not meet the requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the samples condition, the assignable cause of the suture pull off pre-operatively was a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.
Event or Problem Description
It was reported that a patient underwent a robotic bowel resection on (b)(6) 2018 and suture was used.After completing the first pass, the doctor was securing the first knot and the needle separated from the suture.A second like suture was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: SILK SUTURE 30"(75CM) 3-0 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: 8076538
• Report Number: 2210968-2018-77188
• Device Sequence Number: 950323
• Product Code: GAP
• UDI-Device Identifier: 10705031044364
• UDI-Public: 10705031044364
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2018

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: 08/31/2022
• Device Catalogue Number: K832H
• Device Lot Number: LKR974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/15/2018
• Patient Sequence Number: 1