MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 6IN 10-0 D/A CS160-6; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	9001G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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, or its employees that the report constitutes an admission that the product, ethicon, 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The needle dislodged from swage three times.¿several" others noted and not retained.Remaining suture has been quarantined, as suspicion of faulty lot.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/12/2024.H6 component code: g07002 no device problem found.Additional information: d4, d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.The returned sample determined that it was received; a detached needle, a suture piece, and one needle suture piece per the product code 9001.This product code is double-armed.Upon visual inspection of the detached needle, the swage and attachment area were noted as expected.The barrel hole was examined under magnification, and no suture remnant was found.The suture piece was examined and the ends were noted cut probably caused by a surgical instrument.In addition, the needle suture piece was visually inspected, and the swage and attachment area were found as expected.The suture was examined and the end was observed cut.In addition, the functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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: ETHLN BLK 6IN 10-0 D/A CS160-6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19534375
• Report Number: 2210968-2024-06218
• Device Sequence Number: 8337959
• Product Code: GAR
• UDI-Device Identifier: 10705031022324
• UDI-Public: (01)10705031022324(11)230215(17)280131(10)TBMHKB
• 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,Followup
• Report Date (Section B): 06/13/2024

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: 9001G
• Device Lot Number: TBMHKB
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown