MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	683G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.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.The following information was requested, but unavailable: what tissue was being approximated or sutured when it broke? no further information is available.Procedure name and date? no further information is available.Event date? no further information is available.What was used to complete the procedure? no further information is available.
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.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 10/30/2020.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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 Manufacturer Narrative
Date sent to the fda: 11/25/2020.Additional h-3 summary: actual sample: an opened sample with multiple sutures pieces of product code 683, lot # pch054 were received for evaluation.During the visual inspection of opened sample, the strand was received in multiple pieces and unusual color was noted, the suture pieces are not black.Per the sample condition the assignable cause could not be determined.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Rep sample: a sealed sample of product code 683, lot # pch054 was received for evaluation.During the visual inspection of sample, it was noted unusual color of suture.The sample was opened, and the swage and attachment area were noted to be as expected.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.According to sample condition color variation was noted, however, no breakage suture was found.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/19/2021.The following information was requested, but unavailable: please request if the customer uses the hydrogen peroxide vaporization decontamination method.Unopened suture product exposed to hydrogen peroxide vaporization decontamination would eventually cause these black-colored sutures in current overwrap packaging to lose their black color asked the sales rep if the customer uses the hydrogen peroxide vaporization decontamination method, however, he had no information about this.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 SUTURE 18"(45CM) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10623383
• Report Number: 2210968-2020-07597
• Device Sequence Number: 1178843
• Product Code: GAP
• UDI-Device Identifier: 10705031008175
• UDI-Public: 10705031008175
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 09/28/2020

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 Expiration Date: 02/29/2024
• Device Model Number: 683G
• Device Catalogue Number: 683G
• Device Lot Number: PCH054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 11/02/2020; 01/07/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/30/2020; 11/26/2020; 01/19/2021
• Patient Sequence Number: 1