MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 10-0 D/A CS140-8; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	9033G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Component code: (b)(4) device not returned.Additional information was requested, and the following was obtained: what do you mean by "the suture was broken from the beginning"? please explain: it was found that the suture was breaking when the package was opened.Did the suture got broken before it was used in patient or during used it in patient please explain: before use.The following information was requested, but unavailable: did the suture got separated from the needle? please confirm, no.What was used to complete the procedure? no further information is available.Investigation summary: the product was returned for evaluation, and visual inspection of the sample returned was conducted.Visual analysis of the returned product revealed that one opened sample product code 9033g was received for evaluation.The product code is double-armed.Upon visual inspection of the returned sample, excess epoxy was noted between the end barrel needle and the suture.In addition, the two sutures are glued due to excess epoxy.Based on the information currently available, the stringy epoxy defect was identified during the investigation of the sample received.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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 ophthalmic procedure on (b)(6) 2022 and suture was used.After the package was opened, the suture was broken from the beginning.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: ETHLN BLK 12IN 10-0 D/A CS140-8
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14189741
• Report Number: 2210968-2022-02902
• Device Sequence Number: 4406089
• Product Code: GAR
• UDI-Device Identifier: 10705031022515
• UDI-Public: 10705031022515
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 06/30/2026
• Device Model Number: 9033G
• Device Catalogue Number: 9033G
• Device Lot Number: RHBEXR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown