MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 4-0 D/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	D6678
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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: what was the procedure date? what is the lot number? no further information will be provided.
Event or Problem Description
It was reported that a patient underwent an unknown urological surgery on an unknown date and suture was used.During the procedure, the needle was broken, and it fell to the operation room.There were no adverse consequences to the patient.No additional information was provided.

• Brand Name: VCL CT BRD VIO 36IN 4-0 D/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12240151
• Report Number: 2210968-2021-06764
• Device Sequence Number: 14664511
• Product Code: GAM
• UDI-Device Identifier: 10705031026667
• UDI-Public: 10705031026667
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: D6678
• Device Catalogue Number: D6678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1