MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 10-0 D/A CS140-6; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	9003G
Medical Device Problem Code	Material Separation (1562)
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.Additional information was requested, and the following was obtained: was the needle separated from the suture during the intra op event? no.Is this surface suture related issue? no.Did the suture break during the intra op event? no.Lot number? no further information is available.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.When it was used, the suture was loose and could not be handled.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: ETHLN BLK 12IN 10-0 D/A CS140-6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12340225
• Report Number: 2210968-2021-07499
• Device Sequence Number: 3580581
• Product Code: GAR
• UDI-Device Identifier: 10705031022355
• UDI-Public: 10705031022355
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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): 07/30/2021

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: No Information
• Device Model Number: 9003G
• Device Catalogue Number: 9003G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/18/2021
• Patient Sequence Number: 1