MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 3-0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y604H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2023
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.The following information was requested, but unavailable: * please confirm if the suture and the needle were broken (each one) or if the suture broke from the needle.* were there any patient consequences? * were there any unexpected outcomes or complications as a result of the prolonged surgery time? * was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain * please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.--contacted with the sales rep today via phone, please refer to the event description, other information requested is unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) /2023 and suture was used.During the procedure, when the doctor was using suture for the patient, the doctor found that the needle and suture were broken.The doctor immediately took them off the table and kept them, and removed a new one, delaying the process by about 5 minutes.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: MCRYL VIO 27IN 3-0 S/A UR-6
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18016613
• Report Number: 2210968-2023-08248
• Device Sequence Number: 7696279
• Product Code: GAN
• UDI-Device Identifier: 10705031059474
• UDI-Public: 10705031059474
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

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 Catalogue Number: Y604H
• Device Lot Number: TAMQPC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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 Age: 25 YR
• Patient Sex: Male