MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 8-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2808G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 (b)(6) 2019 and a suture was used.During surgery, the suture was detached from the needle during continuous suturing.It was not a control release needle.The suture foil was opened and while the surgeon was about to use it and pulled the suture thread along its length the foil broke.The procedure was completed with a replacement device.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: the actual device was received as a folder with a needle-suture combination of product code 2608.During the visual inspection of the opened sample (needle/suture piece), the swage and attachment area were noted to be as expected.The suture was examined along of strand and near to the end of the suture was crushed that appears to be by the use of a surgical instrument could be observed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: ETHILON SUTURE 5"(13CM) 8-0 BLK
• 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: 8343103
• Report Number: 2210968-2019-78898
• Device Sequence Number: 19359454
• Product Code: GAR
• UDI-Device Identifier: 10705031003934
• UDI-Public: 10705031003934
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 01/18/2019

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 Expiration Date: 04/30/2022
• Device Catalogue Number: 2808G
• Device Lot Number: LEP489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/05/2019
• Patient Sequence Number: 1