MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 10-0 D/A TG160-4; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	7707G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested and not available: lot reported: kk039, is invalid.Please clarify? 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 a patient underwent an unknown procedure on an unknown date and suture was used.The suture kept falling apart in the middle of a procedure.There were no patient consequences reported.There is no additional information available at this time.
Additional Manufacturer Narrative
((b)(4).Additional information: the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: ETHLN BLK 12IN 10-0 D/A TG160-4
• 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: 8110097
• Report Number: 2210968-2018-77372
• Device Sequence Number: 1732640
• Product Code: GAR
• UDI-Device Identifier: 10705031010468
• UDI-Public: 10705031010468
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 08/31/2021
• Device Catalogue Number: 7707G
• Device Lot Number: KKK039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/07/2019
• Patient Sequence Number: 1