MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	663G
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
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts are being 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 in 2018 and a suture was used.During surgery the string broke, and excessive force was not on the string.The case was completed with a replacement.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Evaluation summary ¿ 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 was examined along of strand and the end was cut that appears to be by the use of a surgical instrument.In addition, a functional test was performed and the tensile force were above the minimum requirements.The sample suggests an improper handling of the sample.Representative samples were returned for evaluation.No defects were found on the packet.The samples were opened, and the swage and attachment area were as expected.The sutures were examined along of strand and no defects or breakage suture was found.Functional test was performed on the samples and the tensile force were above the minimum requirements.No suture breakage was found.

• Brand Name: ETHILON SUTURE 18"(45CM) 3-0 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: 7896721
• Report Number: 2210968-2018-75910
• Device Sequence Number: 11121403
• Product Code: GAR
• UDI-Device Identifier: 10705031007772
• UDI-Public: 10705031007772
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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: 01/31/2022
• Device Catalogue Number: 663G
• Device Lot Number: LBH852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 10/28/2018
• Patient Sequence Number: 1