MAUDE Adverse Event Report: ETHICON INC. SILK BLK 10X30IN 1 NON NDL; SUTURE, NONABSORBABLE, SILK

Model Number	SA87G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/03/2020
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 the later date a supplemental medwatch will be sent attempts are being made to clarify 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.Lot number? please clarify if anything other than forceps was used to stop bleeding? any other intervention besides forceps? please specify.Was there any change in the patient's post-operative care due to the event? were there any adverse patient consequences due to the event? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent a mixed hemorrhoid ligation on (b)(6) 2020 and the suture was used.It was reported that the suture broke during knotting vessel resulting in bleeding at the ligated blood vessel.The hemostatic forceps were used to stop bleeding.Then another like suture was used to complete the surgery.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/10/2021.The following information was requested, but unavailable: lot number? please clarify if anything other than forceps was used to stop bleeding? any other intervention besides forceps? please specify.Was there any change in the patient¿s post-operative care due to the event? were there any adverse patient consequences due to the event? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SILK BLK 10X30IN 1 NON NDL
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11204855
• Report Number: 2210968-2021-00515
• Device Sequence Number: 11499849
• Product Code: GAP
• UDI-Device Identifier: 10705031050303
• UDI-Public: 10705031050303
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/28/2020

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: SA87G
• Device Catalogue Number: SA87G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/10/2021
• Patient Sequence Number: 1
• Patient Age: 22 YR