MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 2-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	C012D
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one empty open overwrap packet, one paper lid and one winding former with seven needle-suture combination, a suture and one detached needle that pertain to product code c012d.This product code is multistrand and required eight needle-suture per packet.After an investigation of the suture, no missing suture was observed.However, short insertion was noted in the strand.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement.Based on the information currently available, short insertion issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.
Event or Problem Description
It was reported that a patient underwent a an unknown procedure on an unknown date and suture was used.Before use on the patient, it was found that one suture had been missing.Visual analysis of the returned sample determined that one empty open overwrap packet, one paper lid and one winding former with seven needle-suture combination, a suture and one detached needle that pertain to product code c012d.This product code is multistrand and required eight needle-suture per packet.After an investigation of the suture, no missing suture was observed.However, short insertion was noted in the strand.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement.No adverse patient consequences were reported.

• Brand Name: SILK SUTURE 18"(45CM) 2-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16314798
• Report Number: 2210968-2023-00900
• Device Sequence Number: 20414788
• Product Code: GAP
• UDI-Device Identifier: 10705031023390
• UDI-Public: 10705031023390
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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: C012D
• Device Catalogue Number: C012D
• Device Lot Number: SEBCJA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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