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

Model Number	M653G
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
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.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 via: was there any change in the patient¿s post-operative care due to the prolonged procedure? no.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2022-09587.
Event or Problem Description
It was reported that a patient underwent a sternotomy procedure on (b)(6) 2022 and suture was used.During the procedure, in a trauma surgery opens aciflex caliber 5 and it is observed that the diameter was smaller than the size that is real.Very thin suture gauge was observed.Another suture is opened and the same is observed.No adverse patient consequences were reported.Additional information was requested.
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.The following information was obtained: the sample is en route.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 4/25/2023.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned samples determined that it was received three open samples that pertain to product code m653g.This product code is multistrand and required four strands per packet.Upon visual inspection of the returned samples, the needle sutures were dispensed without problems.The sutures were examined, and no anomalies or defects were observed.In addition, the sutures were measured, and the results met with the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no anomalies were noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A device has been received for product code m653g lot ap9632, however clarification is requested whether the product belongs to this complaint.Our failure analysis lab received the additional products with reference to this complaint, the following product was received: product code: m653g.Product received: ap9632.This complaint is for product code m653g, lot an8487.Could you please clarify if additional device belongs to this complaint? 1a.If yes, did a device malfunction occur during the same procedure for both lots ap9632 & an8487? if not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.If the device was not reported before, please provide more details of device malfunction.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be 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.Related reports: 2210968-2022-09587.

• 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.-BRAZIL; robert- koch strass1; km 154; sao paolo ; BR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15822521
• Report Number: 2210968-2022-09586
• Device Sequence Number: 6223074
• Product Code: GAQ
• UDI-Device Identifier: 10705031045477
• UDI-Public: 10705031045477
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 04/25/2023

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 Expiration Date: 07/31/2025
• Device Model Number: M653G
• Device Catalogue Number: M653G
• Device Lot Number: AN8487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2022
• Supplement Date Received by Manufacturer: 02/06/2023; 04/11/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/13/2023; 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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