MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 5 S/A CCS; SUTURE, NONABSORBABLE, STEEL

Catalog Number	M653G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); Osteopenia/ Osteoporosis (2651)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.H6 component code: g07002 device not returned.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did the patient experience a wound dehiscence? confirm the initial cabg was on 8/14/2024.When did the wound breakdown and osteoporosis occur? is the wound breakdown related to the use of the wire? please explain.Is the osteoporosis related to the use of the wire? please explain.Is the bone cutting through the chest wall related to the use of the wire? please explain.What was the patient¿s tissue condition (normal, thin, calcified, fragile, diseased)? were there any patient stress factors that precipitated the event of sternum wire breakage? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement? please describe the appearance of the suture during the second procedure.What symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
Event or Problem Description
Sit was reported that a patient underwent a reoperation because the steel wire broke after cabg.The reoperation took place on (b)(6) 2024.Post second implant, patient developed wound breakdown due to osteoporosis and bone cut through.The wire was all still intact.Patient is now in care of national heart centre for pectoralis flap under plastic surgeon.Additional information was requested.

• Brand Name: STLESS STEEL SIL 4X18IN 5 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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20626389
• Report Number: 2210968-2024-11581
• Device Sequence Number: 7534916
• Product Code: GAQ
• UDI-Device Identifier: 10705031045477
• UDI-Public: (01)10705031045477(17)280331(10)TDBEEJ
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M653G
• Device Lot Number: TDBEEJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 81 KG