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

Model Number	1674H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot peh821, and no non-conformance's were identified.Investigation summary: unopened samples, a representative opened sample and an empty overwrap packet of product code 1674, lot # peh821 were returned for analysis.The complaint sample was not received.During the visual inspection the unopened samples, no defects were found on the packages.The swage and attachment area of eleven samples were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.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 samples received, no performance - breakage suture was found and the tested samples met the finished goods requirements.Additional information was requested and the following was obtained: what tissue was being approximated or sutured when it broke? unsure about the tissue layers (possible fascia) what was used to complete the procedure? unsure about what was used instead.It was reported that multiple were broken; how many devices were involved in this single procedure? there was multiple sutures reported broken by different procedures and surgeons (unsure of exact number/cases).The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts were made to obtain the information.If 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 an unknown date and suture was used.During the procedure, the suture kept breaking.There were no adverse patient consequences.No additional information was reported.

• 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
• MDR Report Key: 9814526
• Report Number: 2210968-2020-01903
• Device Sequence Number: 1551641
• Product Code: GAR
• UDI-Device Identifier: 10705031001930
• UDI-Public: 10705031001930
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 02/14/2020

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: 04/30/2024
• Device Model Number: 1674H
• Device Catalogue Number: 1674H
• Device Lot Number: PEH821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/10/2020
• Patient Sequence Number: 1