MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	662H
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).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the name of the initial procedure? could you please provide lot number? 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 an unknown date; and a suture was used.During the procedure, the suture broke.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/29/2020.Additional information was requested and the following was obtained: were there any adverse patient consequences? no.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number pdh346, and no non-conformances related to the reported complaint condition were identified.Additional h3 investigation summary: an opened sample of product code 662, lot # pdh346 was returned for analysis.During the visual inspection of the open sample, the swage and attachment area were noted to be as expected.The suture was received partially dispensed and no defects, damaged or suture breakage were noted.The strand was measured for length on calibrated scale and the results met with the finished goods requirements for 18¿ length.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, no performance - breakage suture was found and the tested sample met the finished goods requirements.

• Brand Name: ETHILON SUTURE 18"(45CM) 4-0 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: 9991830
• Report Number: 2210968-2020-03424
• Device Sequence Number: 17264034
• Product Code: GAR
• UDI-Device Identifier: 10705031007741
• UDI-Public: 10705031007741
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/17/2020

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: 03/31/2024
• Device Model Number: 662H
• Device Catalogue Number: 662H
• Device Lot Number: PDH346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 06/03/2020; 06/26/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 06/09/2020; 06/29/2020
• Patient Sequence Number: 1