MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 5-0 S/A TF-5; SUTURE, NONABSORBABLE, SILK

Catalog Number	N271H
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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 unknown procedure on an unknown date and suture was used.During the procedure, a sample product was opened to examine for a doctor and the outside of the box said it was a 5/8 inch circle needle but the actual needle appeared to a half inch circle.There were no adverse patient consequences.No additional information as provided.
Additional Manufacturer Narrative
(b)(4).
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 were met prior to the release of this lot.Investigation summary a needle-suture combination within a folder into opened foil was returned for evaluation.During the visual inspection of the sample, the needle-suture combination was dispensed and the swage and attachment area of the needle were as expected.Also, the needle was comparison with the needle specification and meet the curve tolerance shadow lines.Per the condition of the sample, no incorrect component was found.

• Brand Name: SILK BLK 18IN 5-0 S/A TF-5
• 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: 7619315
• Report Number: 2210968-2018-73578
• Device Sequence Number: 1242902
• Product Code: GAP
• UDI-Device Identifier: 10705031047365
• UDI-Public: 10705031047365
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 05/25/2018

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: 02/28/2023
• Device Catalogue Number: N271H
• Device Lot Number: MCQ414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018; 06/21/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 06/20/2018; 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1