MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 0 S/A SH; SUTURE, NONABSORBABLE, SILK

Model Number	K834H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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.Additional information was requested, and the following was obtained: please provide the lot number for the stratafix spiral monocryl plus (product code: sxmp1b118).Lot #rhbbla please provide the lot number for the silk suture (product code k834h).Lot #rcbbka when did the sutures broke (in the package, during removal from package, during handling or during use on the patient)? please specify for both of the two sutures.During use on the patient for both sutures a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2021-10501.
Event or Problem Description
It was reported that a patient underwent a coronary procedure on (b)(6) 2021 and suture was used.During the surgery, the suture broke.Another like device was used to complete the surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/29/2021.H3 investigational narrative: visual analysis of the returned product revealed that one opened sample product code k834 was received to ethicon inc for evaluation.Upon visual inspection of the returned sample, the suture end was observed to have damaged and was broken due to stress applied.In addition, no damaged caused by surgical instrument or use were observed.The length suture was measured and did not meet the requirement due to returned condition of the sample.The damaged suture defect has been correlated to the manufacturing process.Based on the information currently available, the damaged suture defect was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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 BLK 30IN 0 S/A SH
• 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: 12738370
• Report Number: 2210968-2021-10738
• Device Sequence Number: 8842609
• Product Code: GAP
• UDI-Device Identifier: 10705031044418
• UDI-Public: 10705031044418
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: 02/28/2026
• Device Model Number: K834H
• Device Catalogue Number: K834H
• Device Lot Number: RCBBKA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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