MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 5IN 9-0 S/A V100-3; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2894G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2018
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.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 a free flap reconstruction procedure on (b)(6) 2018 and suture was used.During the procedure, while performing micro vascular anastomosis, the suture broke mid-body.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The actual sample was returned for evaluation.During the visual inspection of needle/suture piece, the swage and attachment area were as expected.The suture piece present body fluids, several damages (dent) along of strand and end suture was cut that appears to be by use of the surgical instrument.Functional test was performed on the sample and the sample met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the open sample condition, the assignable cause, suggests an improper handling of the sample.

• Brand Name: ETHLN BLK 5IN 9-0 S/A V100-3
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7479422
• Report Number: 2210968-2018-72518
• Device Sequence Number: 16472417
• Product Code: GAR
• UDI-Device Identifier: 10705031004276
• UDI-Public: 10705031004276
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2018

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: 09/30/2022
• Device Catalogue Number: 2894G
• Device Lot Number: LLZ332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 05/03/2018; 06/06/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 05/29/2018; 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1