MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 5-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	K870H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested, and the following information was obtained: did the surgery was completed successfully? no further information is available.What was used to complete the procedure? no further information is available.What is the event day and procedure date? no further information is available.Device return follow up.The device has been received at (b)(6), and will be shipped.Please check rmao.No further information will be provided.
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.No additional information was provided.
Additional Manufacturer Narrative
(b)(4), date sent to the fda: 2/1/2021.Additional information: d9, h4, h6.A manufacturing record evaluation was performed for the finished device batch pdh405, and no non-conformances were identified.H6 component code: g07002 incomplete device returned.Additional h3 investigation summary: two empty overwrap packet and three empty labeled winding former of product code k870, lot # pdh405 were received for evaluation.Needle or suture was not returned.If additional information is made available, the investigation will be updated as applicable.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.It should be noted that as part of our quality process, 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.

• Brand Name: SILK SUTURE 30"(75CM) 5-0 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: 11051619
• Report Number: 2210968-2020-10150
• Device Sequence Number: 1257242
• Product Code: GAP
• UDI-Device Identifier: 10705031044548
• UDI-Public: 10705031044548
• 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
• Report Date (Section B): 12/04/2020

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: No Information
• Device Expiration Date: 03/31/2024
• Device Model Number: K870H
• Device Catalogue Number: K870H
• Device Lot Number: PDH405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1