MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 36"(90CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J347H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mbz441 number, 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.The following information was requested, but unavailable: please make 3 attempts to obtain the following information: what tissue was the needle/ suture combination being used on? what was the condition of the tissue (healthy, diseased, fragile, weakened)? did the needle break and the broken piece fell into the patient? what tissue was the needle located in? did the suture break and the whole needle with suture attached fell in the patient? can you clarify ¿the suture could not be located¿? can you clarify ¿the suture was removed under image intensified¿? or did you mean the ¿needle was removed¿? what date was the second procedure to remove the device under image intensifier? were all of the needle pieces removed from the patient? what is the current condition of the patient?.
Event or Problem Description
It was reported that the patient underwent a gynecological surgery on an unknown date and suture was used.During the procedure, the suture broke approximately two-thirds of the way down the needle shaft.The suture could not be located.The patient was x-rayed post-procedure and the needle could be seen.The surgeon sent the patient to the nearest tertiary hospital where the suture needle was located and removed under image intensifier as the hospital where the incident happened does not have an image intensifier.No additional information was available.

• Brand Name: VICRYL SUTURE 36"(90CM) 1 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8463845
• Report Number: 2210968-2019-79799
• Device Sequence Number: 198665
• Product Code: GAM
• UDI-Device Identifier: 10705031039131
• UDI-Public: 10705031039131
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022269
• 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
• Report Date (Section B): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: J347H
• Device Lot Number: MBZ441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention