MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 7 S/A CCS; SUTURE, NONABSORBABLE, STEEL

Catalog Number	M655G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned 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.Photo analysis: this is an analysis for a photo submitted for evaluation.During the visual analysis, the following was observed: the picture shows a package with product code m655.The image is not clear to determine the failure mode or the reported condition.Based on the photo review, the event describe is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional information was requested, and the following was obtained via: was there any adverse consequence associated with the patient? no.Breakage was discovered as it happened so it was addressed at the time.Please provide the lot number: xjm655.P31.I believe i uploaded a picture of the package.If you still need that, let me know please provide the source or name of person providing answers to follow-up questions: bonnie abram, dr (b)(6).Events reported via: 2210968-2023-09486, 2210968-2023-09488.
Event or Problem Description
It was reported that a patient underwent a cabg procedure in 2023 and suture was used.During the procedure, the sales rep reported that the sternal wires (item # m655) have been breaking while twisting and applying slight pressure.The surgeon and pa simply used other wires to complete the sternal closure without any harm to the patient.No delays and no fragments made.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: STLESS STEEL SIL 4X18IN 7 S/A CCS
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18269848
• Report Number: 2210968-2023-09487
• Device Sequence Number: 17132238
• Product Code: GAQ
• UDI-Device Identifier: 10705031045491
• UDI-Public: 10705031045491
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2023

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 Catalogue Number: M655G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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