MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J464G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4); (b)(4).Additional information was requested, and the following was obtained: please clarify how the procedure was complete.Surgeon closed as normal.No needle was detected via xray; size of the needle piece retained? unknown.Was more than half the needle retained in the patient? unknown.Are any plans in place to remove the needle piece in future? not at this time.Was there any additional tissue damage as a result of searching for the needle piece? none at this time.Please provide procedure date unknown.Patient¿s current status? normal recovery.The lot number provided, pl5797, corresponds to umbilical tape (u16g), and not suture.To date, it has been reported that the device will not be returned.If the device, or further details are received at a later date, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent a peroneal laceration procedure post vaginal delivery and suture was used.The needle broke during the hernia repair post-delivery.The patient was sent for x-ray, but the needle was not found.The patient recovered normally.There were no adverse patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 01/14/2021.The following information was requested, but unavailable: can you please provide the lot number for the vicryl suture (j464g) used in this event? 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.

• Brand Name: VCL CT BRD VIO 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11013682
• Report Number: 2210968-2020-09940
• Device Sequence Number: 3594550
• Product Code: GAM
• UDI-Device Identifier: 10705031040151
• UDI-Public: 10705031040151
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: Health Professional
• Device Model Number: J464G
• Device Catalogue Number: J464G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/14/2021
• Patient Sequence Number: 1