MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	1673H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot mbj028, and no non-conformance's were identified.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 an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the suture broke very easily.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 04/17/2020.Additional h3 investigation summary a paper lid and a used suture piece of product code 1673b, lot # mbj028 were returned for analysis.During the visual inspection of suture, the suture ends were noted with lineal cut that appears to be by use of a surgical instrument.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample, the assignable cause of the performance - breakage suture was an improper handling.In addition, the tested samples met the finished goods requirements.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 03/25/2020.

• Brand Name: ETHILON SUTURE 30"(75CM) 3-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9756775
• Report Number: 2210968-2020-01519
• Device Sequence Number: 19621472
• Product Code: GAR
• UDI-Device Identifier: 10705031001923
• UDI-Public: 10705031001923
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Followup
• Report Date (Section B): 01/30/2020

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: 01/31/2023
• Device Model Number: 1673H
• Device Catalogue Number: 1673H
• Device Lot Number: MBJ028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/25/2020; 03/25/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/25/2020; 04/17/2020
• Patient Sequence Number: 1