MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30IN(75CM) 5-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	F2413H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 batch number plr214, and no non-conformances were identified.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 information was obtained: additional event information received on (b)(6) 2020 from no patient consequence.The surgeon had to take over stitches from the supra-dermal overjet which had become uncertain because it is a supra-dermal overjet made by ethilon 5-0.The device was discarded.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on an unknown date and a suture was used.During the procedure, the suture pulled off the needle.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/12/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional h3 investigation summary: five pictures were received for evaluation.Upon visual inspection of the pictures, an empty labeled winding former, a overwrap packet an opened box and a detached needle of product code f2413h, lot # plr214 could be observed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as on what caused the reported complaint, since the sample was not returned for analysis.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.

• Brand Name: ETHILON SUTURE 30IN(75CM) 5-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11143143
• Report Number: 2210968-2021-00187
• Device Sequence Number: 4042506
• Product Code: GAR
• UDI-Device Identifier: 10705031238916
• UDI-Public: 10705031238916
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: No Information
• Device Expiration Date: 09/30/2024
• Device Model Number: F2413H
• Device Catalogue Number: F2413H
• Device Lot Number: PLR214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/12/2021
• Patient Sequence Number: 1