MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 4 X 30"(75CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8709
Medical Device Problem Codes	Material Separation (1562); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
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.H3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.The returned sample determined that it was received, one straight packet that pertained to product code epm8709.This product code is multistrand and requires four strands double armed per packet.Upon visual inspection of the returned sample, it was noted the two strands double armed outside of the foam park and tangled with them.The foam park was examined, and it is not possible to determine if there were fewer strands than required.The swage and attachment area of needles were noted as expected.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.Additionally, it was found that the straight packet was open, and the lock tab was cut.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.The manufacturing records could not be reviewed as the batch/lot number is unknown.Additional information was requested, and the following was obtained via: - was there any adverse consequence associated with the patient? no - please provide the lot number: i don¿t have it - please provide the source or name of person providing answers to follow-up questions: (b)(6) - was there any adverse consequence associated with the patient? other than being on pump longer than expected due to having to find needles and having to access better tissue each time the doc would pass the needle, it would pop off, then he would have to redo the pass.- please provide the lot number: i don¿t have it - device return status.Please document the shipment tracking number: i took to fed ex on tuesday - please provide the source or name of person providing answers to follow-up questions: i have been asking the charge nurse for details.Her name is (b)(6).
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2024 and suture was used.During the procedure, the sales rep reported that the tech opened and only saw 2 strands/4 needles in a package that should have 4 strands/8 needles.Each time the doc would pass the needle, it would pop off, then he would have to redo the pass.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PROLENE SUTURE 4 X 30"(75CM) 6-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18669296
• Report Number: 2210968-2024-01152
• Device Sequence Number: 17971228
• Product Code: GAW
• UDI-Device Identifier: 10705031207417
• UDI-Public: 10705031207417
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2024

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: EPM8709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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