MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J840D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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 done to retrieve the broken piece? i have not been able to get any other information.Was the needle piece retrieved during the same procedure? i have not been able to get any other information.Was additional dissection required in other organs/tissues other than the target tissue as a result of searching for the needle piece? i have not been able to get any other information.Were there any patient consequences? i have not been able to get any other information.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.
Event or Problem Description
It was reported that a patient underwent a spinal procedure on (b)(6) 2021 and suture was used.During the procedure, the needle broke.The needle was retrieved.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 8X18IN 0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11889359
• Report Number: 2210968-2021-04972
• Device Sequence Number: 3249002
• Product Code: GAM
• UDI-Device Identifier: 10705031043237
• UDI-Public: 10705031043237
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 05/04/2021

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 Expiration Date: 08/31/2025
• Device Model Number: J840D
• Device Catalogue Number: J840D
• Device Lot Number: QKMHPC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1