MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 2-0 S/A FS; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	664H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 09/29/2021.(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.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.Could you please provide the lot number? were there any patient consequences?.
Event or Problem Description
It was reported that a patient underwent a re-do left craniotomy procedure on (b)(6) 2021 and suture was used.During the procedure, the suture was catching on itself, sticking the entire way.The suture was pulled hard to get the knot down and the suture broke.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: ETHLN BLK 18IN 2-0 S/A FS
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12546392
• Report Number: 2210968-2021-08961
• Device Sequence Number: 5338011
• Product Code: GAR
• UDI-Device Identifier: 10705031007826
• UDI-Public: 10705031007826
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/01/2021

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: 664H
• Device Catalogue Number: 664H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1