MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 5-0 S/A FS-2; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	661H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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.When did the issue occur; in the package/ during dispensing (before use on patient/during actual suturing (use on patient)? device return status/follow up?.
Event or Problem Description
It was reported that the patient underwent a pediatric plastic surgery on (b)(6) 2019 and the suture was used.It was reported that the suture loses the needle easily.Another like suture was used to complete the procedure.There were no patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 02/03/2020.A manufacturing record evaluation was performed for the finished device lot pbq267 , and no non-conformances were identified.Additional h3 investigation summary: an open box with unopened samples of product code 661h, lot # pbq267 were returned for analysis.During the visual inspection of the unopened samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the sample received, no performance detached needle was found, and the tested sample met the finished goods requirements.Additional information was requested and the following was obtained: when did the issue occur; in the package/ during dispensing (before use on patient/during actual suturing (use on patient)? unknown.

• Brand Name: ETHLN BLK 18IN 5-0 S/A FS-2
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9579369
• Report Number: 2210968-2020-00278
• Device Sequence Number: 2196979
• Product Code: GAR
• UDI-Device Identifier: 10705031007703
• UDI-Public: 10705031007703
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 12/16/2019

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: 01/31/2024
• Device Model Number: 661H
• Device Catalogue Number: 661H
• Device Lot Number: PBQ267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/12/2020
• Supplement Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1