MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 2-0 S/A CP-2 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J762D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been made to retrieve the device.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: was the needle removed from the patient during the same procedure? yes.What is the condition of the patient? no issues.What tissue/location was suturing when needle came off occurred? knee.Procedure name and date? total knee.
Event or Problem Description
It was reported that a patient underwent a total knee on (b)(6) 2020, and suture was used.The needle made one pass into the skin and the needle came off.This happened before the surgeon gave it a good pull.The needle was not wedged on very good.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 8X18IN 2-0 S/A CP-2 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10732328
• Report Number: 2210968-2020-08314
• Device Sequence Number: 11591316
• Product Code: GAM
• UDI-Device Identifier: 10705031042810
• UDI-Public: 10705031042810
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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 Expiration Date: 01/31/2025
• Device Model Number: J762D
• Device Catalogue Number: J762D
• Device Lot Number: QBMHDK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1