MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	C017D
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke, and it was reported the suture pulled off of the needle.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested, and the following was obtained: was the needle piece removed from the patient during the same procedure? yes.Did the pull off occurred during use on the patient or upon handling before use on the patient? unknown.Please clarify/specify if j602h and c017d are also involved in this same event (suture pulled off from needle) during same procedure on same patient? yes, according to or¿s reply.If more than one procedure was affected, were these previously reported to ethicon? if yes, can you provide a product complaint number.No.If not previously reported, please provide.Procedure date: unknown.Product code: w8977, j602h, c017d.Lot number: meq548, n/a, maj092.Quantity involved in each procedure: 1, 1, 1.Event description stating when each involved device had a suture breakage issue in the procedure.Hospital did not provide the detail in procedure.In surgery, they used the j602h, c017d which had suture breakage and they also found foreign matter in w8977 but they did not use w8977.Were there any adverse patient consequences? no.Is the foreign matter non biological or biological material? unknown.Device return status/follow up? receive return product on (b)(6) 2021 from customer.Related to: 2210968-2022-00096.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/09/2022.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.H3 evaluation: the product was returned for evaluation.Upon visual analysis of the returned product revealed that one sample product code c017 was received for evaluation with the packaging previously opened.The product is control release, and each packet should contain eight strands.During the analysis of the returned product the needle from slot # 1 was received without sutures and the swage and attachment area were noted to be as expected, no marks due to use were observed.Functional test was performed, and the pull force and tensile strength results were above the minimum requirements.The swage and attachment area of the seven needles were noted to be as expected.The sutures were dispensed without problems and examined along of the strand to detect any issue on the suture and no defects were observed during evaluation as part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: SILK SUTURE 30"(75CM) 3-0 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 PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13172433
• Report Number: 2210968-2022-00095
• Device Sequence Number: 4517891
• Product Code: GAP
• UDI-Device Identifier: 10705031023499
• UDI-Public: 10705031023499
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 01/05/2022

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 Expiration Date: 12/31/2022
• Device Model Number: C017D
• Device Catalogue Number: C017D
• Device Lot Number: MAJ092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2018
• 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