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	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2024 and suture was used.During the passage of the steel wire through the patient's sternum for osteosynthesis, the tip of the needle had broken off and fallen into the patient.The tip of the needle was found.No patient consequence was reported.Additional information was requested.
Additional Manufacturer Narrative
(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.Additional information was requested, and the following was obtained: what was done to retrieve the broken piece? for example, another incision, or second surgery? no other surgery procedure was performed.Retrieval directly in the patient.Was there any additional tissue damage as a result of searching for the needle piece? no because no additional surgery procedure performed.Were there any patient consequences? no.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/4/2024.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Additional information was requested, the following was obtained: what was done to retrieve the broken piece? for example, another incision, or second surgery? no other surgery procedure was performed.Retrieval directly in the patient.Was there any additional tissue damage as a result of searching for the needle piece? no because no additional surgery procedure performed.Were there any patient consequences? no.There were no consequences for the patient following this incident because the tip of the needle which had fallen into the patient was found and could therefore be removed.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: 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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18986219
• Report Number: 2210968-2024-03504
• Device Sequence Number: 8208901
• Product Code: GAQ
• UDI-Device Identifier: 10705031045491
• UDI-Public: 10705031045491
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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
• Device Lot Number: THBBCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• 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
• Patient Sex: Unknown