MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 3-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J864D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please confirm when the needle breakage occurred: pre-op, intra-op, or post-op.It was reported that the needle fragment was found on the back table, was the defective needle actually used on the patient? which tissues were being sutured at the time of needle breakage? did the broken needle cause any damage to the tissue while suturing? were x-rays conducted to locate any possible needle fragments remaining in the patient? 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.
Event or Problem Description
It was reported that a patient underwent a lumpectomy procedure on (b)(6) 2022 and suture was used.The needle was returned to the needle book it was noticed that the tip of the needle was missing.Missing piece was found on the back table.Another like device was used to complete the procedure.There were no adverse consequences for the patient.Additional information was requested.

• Brand Name: VCL CT BRD UD 8X18IN 3-0 S/A SH CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13699499
• Report Number: 2210968-2022-01563
• Device Sequence Number: 17752370
• Product Code: GAM
• UDI-Device Identifier: 10705031000278
• UDI-Public: 10705031000278
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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: J864D
• Device Catalogue Number: J864D
• Device Lot Number: RMMAJX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown