MAUDE Adverse Event Report: ETHICON INC. ETHILON SUT 18IN(45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	662SLH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.During the procedure, the suture became detached from the needle.The thread broke off the needle, has happened 10 times there were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: g07002 - device not returned.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.Additional information was requested, the following was obtained: please provide the lot number: scbbm.Was a patient involved ? yes.Was suture used on a human ? yes.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? how long (in minutes) did the surgery prolong? unknown.What tissue was being sutured when the event occurred? unknown.Was additional dissection required in other organs/tissues other than the target tissue? unknown.Was there any change in the patient¿s post operative care due to the prolonged procedure? unknown.The following information was received: procedure: suture course wet lab.When did the even occur (pre-op/intra-op/post-op)? during suturing skin, directly after opening package.Was there any patient consequence? no.What action was taken to resolve the issue? new suture had to be taken.How long was the procedure prolonged as a result of the difficulties encountered with the device (minutes)? 2 minutes.The following information was requested: please verify the lot number.Scbbm is not valid.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.Related reports: 2210968-2023-01040, 2210968-2023-01041, 2210968-2023-01042, 2210968-2023-01043, 2210968-2023-01044, 2210968-2023-01046, 2210968-2023-01047, 2210968-2023-01048, and 2210968-2023-01049.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/16/2023.Additional information was requested, the following was obtained: -was a patient involved ? no.-was suture used on a human ? no.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.Product complaint # (b)(4).Date sent to the fda: 2/16/2023.Corrected information: additional information was received that this event no longer meets malfunction reporting criteria.This medwatch report is no longer reportable.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: ETHILON SUT 18IN(45CM) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• 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 ; 9083863534
• MDR Report Key: 16371197
• Report Number: 2210968-2023-01045
• Device Sequence Number: 17845914
• Product Code: GAR
• UDI-Device Identifier: 10705031239548
• UDI-Public: 10705031239548
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 662SLH
• Device Catalogue Number: 662SLH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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