MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 5IN 11-0 S/A BV50-3; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2881G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
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.It was reported that the suture detached from the needle.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4) date sent to the fda: 9/19/2024 h6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: when did the needle detach or pull off from the suture (in the package, during removal from the package, during handling prior to using on the patient, or during use on the patient)? please confirm the quantity of devices involved from lot number temclh: please confirm the quantity of devices involved from lot number tjmkcz: -please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or (b)(6).Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.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 Manufacturer Narrative
Product complaint # (b)(4).H3 evaluation: the product was returned to ethicon for evaluation.One open folder, one needle, and a suture piece were received for analysis.Product code.Upon initial inspection of the returned sample, the suture was found to be taped to the folder.The suture broke when attempting to remove it from the tape.The needle was examined and the attachment condition was as expected.The barrel hole of the needle was examined with magnification, and no suture remnant was noted.As per the conditions of the returned sample, no functional test could be performed.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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.A manufacturing record evaluation was performed for the finished device lot number, and no related 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.

• Brand Name: ETHLN BLK 5IN 11-0 S/A BV50-3
• 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: 20256547
• Report Number: 2210968-2024-10008
• Device Sequence Number: 8014134
• Product Code: GAR
• UDI-Device Identifier: 10705031004191
• UDI-Public: (01)10705031004191(17)280731(10)TJMKCZ
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 11/13/2024

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: 2881G
• Device Lot Number: TJMKCZ
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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