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)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: was surgery delayed due to the reported event? --> unknown.Was procedure successfully completed? --> unknown.Were fragments generated? --> unknown.If yes, were they removed easily without additional intervention? --> unknown.Patient status/ outcome / consequences --> no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.When the doctor use the suture during surgery, the suture broke easily.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/06/2020.Additional h3 device evaluation summary: an opened sample of product code 662, lot # pdh912 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 dispensed 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 sample, no performance - breakage suture was found and the tested sample met the finished goods requirements.A manufacturing record evaluation was performed for the finished device lot number pdh912, and no non-conformances related to the reported complaint condition were identified.

• 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: 9485461
• Report Number: 2210968-2019-91025
• Device Sequence Number: 209551
• 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
• Report Date (Section B): 11/27/2019

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: PDH912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/06/2020
• Patient Sequence Number: 1