MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 5-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J391H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.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 via: doctor performed bilateral third eyelid gland repairs on a patient.An e collar was placed on the patient though there was possibly some ability for the patient to rub its eyes.The patient returned for a recheck and the doctor noted that the sutures were broken at the midway point of the left eye by day 3 and the right one by day 7.A second surgery was performed on the left eye again as the glad had prolapsed again on day 4.The patient¿s left eye was rechecked on day 14 post second surgery and the eyes appeared healed.The e collar was removed and the patient was cleared to go back to normal activity.The client called after an hour after the recheck exam to relay that the left third eyelid gland had prolapsed.The client reported he could see the suture broken again in the middle of the suture, though the doctor never saw this patient again with the suture embedded in the third eyelid.He took the patient for a second opinion to a local ophthalmologist who removed the suture.Dr.(b)(6) spoke with another ophthalmologist that comes to our hospital to ask if the surgeries failed from technique issues or if it was possibly gland challenges with this patient in particular.Given that she had not had this problem on any previous surgeries and the fact that another doctor, dr.Bailey, had a failure of the same procedure on another patient, the ophthalmologist felt it was best to discontinue using the same box of sutures and try the repairs again with a new lot.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2023-04321 and 2210968-2023-04322.
Event or Problem Description
It was reported an animal underwent an eye procedure on (b)(6) 2023 and suture was used.Post-op, it was reported a failed cherry eye surgeries recently and the specialist said it was possibly due to the sutures since this is usually a highly successful surgery.¿ on june 5, 2023, additional information was received indicating the suture broke.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 18IN 5-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17134164
• Report Number: 2210968-2023-04322
• Device Sequence Number: 15064974
• Product Code: GAM
• UDI-Device Identifier: 10705031039513
• UDI-Public: 10705031039513
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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: 02/28/2025
• Device Model Number: J391H
• Device Catalogue Number: J391H
• Device Lot Number: QCMJUT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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