MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 36IN 0 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J958H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 piece(s) retrieved? yes.Were x-rays taken to locate the needle piece(s)? no.What was the size of the needle used? unknown.Lot number? unknown, packaging discarded; are any samples available of evaluation? no, discarded.
Event or Problem Description
It was reported that a patient underwent an incision closure procedure on (b)(6) 2022 and suture was used.The tip of needle broke off in the needle holder.The tip was collected and placed on the magnet needle count board.The remaining needle and broken tip were placed together, in needle count board to account for entire needle.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 36IN 0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14337080
• Report Number: 2210968-2022-03491
• Device Sequence Number: 6200312
• Product Code: GAM
• UDI-Device Identifier: 10705031043725
• UDI-Public: 10705031043725
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

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: J958H
• Device Catalogue Number: J958H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female