MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30"(75CM) 2-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1674H
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).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 a procedure for a washout and incision and drainage of right wound infection on an unknown day in (b)(6) 2018 and suture was used.Surgeon was using suture 2-0 ethilon when she stated the tip broke off inside the patient.The scrub technician, surgeon, and pa were able to locate the tip of the needle.All three verified they found both pieces.The tip and rest of the needle were bagged.The device is not available for return.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 12/11/2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: ETHILON SUTURE 30"(75CM) 2-0 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: 8089993
• Report Number: 2210968-2018-77245
• Device Sequence Number: 1747614
• Product Code: GAR
• UDI-Device Identifier: 10705031001930
• UDI-Public: 10705031001930
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 03/31/2023
• Device Catalogue Number: 1674H
• Device Lot Number: MDH668
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/11/2018
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 85