MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 2-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	664G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and suture was used.During the procedure, the tip of the suture needle broke off.The needle was compared to another fs of the same size to deduce that it was around a 1mm fragment missing.Radiographers x-rayed the patient after confirming a fragment this size could be seen.The surgeon ruled out that the fragment was inside the patient, after x-ray.They continued the case and finished without any problem.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4) date sent to the fda: 2/21/2024 h6 component code: g07002 - device not returned h6 component code: c22 - photo analysis 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: 1.Can you please clarify if the fragment was retained in the patient? as per the event description, "radiographers xrayed the patient after confirming a fragment this size could be seen" answer - no fragment in patient, confirmed by surgeon & xray 2.If the fragment was retained, is the surgeon planning to remove it? answer - fragment not in patient 3.Can you please advise how long the associated delay was? has the patient shown any signs of developing an ssi due to the delay? answer - no information provided on ssi or associated delay 4.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) answer ¿ unknown 1.Were there any patient consequences? if yes, please provide more details.No patient consequences, noted in customer letter 2.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? unknown 3.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) all questions go back to (b)(6).The following information was reported: was surgery delayed due to the reported event? yes, if yes, number of minutes: unknown , was procedure successfully completed? yes, were fragments generated? yes, if yes, were they removed easily without additional intervention? yes, patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no fragment left inside patient.Procedure completed., was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, is the patient part of a clinical study unknown photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a needle with a broken tip held by the user.Based on the photo review, 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 complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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.

• Brand Name: ETHILON SUTURE 18"(45CM) 2-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 18748051
• Report Number: 2210968-2024-01601
• Device Sequence Number: 6271118
• Product Code: GAR
• UDI-Device Identifier: 10705031007819
• UDI-Public: 10705031007819
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2024

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: 664G
• Device Lot Number: SDBHCQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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