MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 10-0 D/A CS160-6; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	9000G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.It was reported that they are having issues with this suture breaking off the needles while in use and when we load.It has happened quite a few times now.No patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 1/6/2024.H6 component code: g07002 - device not 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.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: please note the lot number has been confirmed as tcbexe.Could you please confirm the number of sutures that broke off from the needle during this procedure? if possible, please specify how many "during use" and how many during "load".Unknown but it was confirmed as at least 3 over multiple cases.Were there any patient consequences within the reported procedure? no patient consequences.Were any fragments generated? if so, were they removed without additional intervention? no.Was there any additional medical or surgical intervention performed? no.It was reported within the event description "it has happened quite a few times now." could you please confirm the specific number of patient events? please provide all the relevant details as above, no further information to provide.Have any of these events been previously reported to ethicon? if yes, could you please provide the pc no.? no, this is the first pc related to this.Was there any adverse patient outcome within the previous instances? no.Was there any additional medical or surgical intervention performed? no.The following information was received: was surgery delayed due to the reported event? unknown.Was procedure successfully completed? yes.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required? unknown.Is the patient part of a clinical study? unknown.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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.Related reports: 2210968-2024-00186 and 2210968-2024-00189.

• Brand Name: ETHLN BLK 12IN 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.-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: 18465502
• Report Number: 2210968-2024-00188
• Device Sequence Number: 16935533
• Product Code: GAR
• UDI-Device Identifier: 10705031022300
• UDI-Public: 10705031022300
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 9000G
• Device Lot Number: TCBEXE
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• 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