MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X18IN 8-0 D/A BV130-5 EP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	EPM8738
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Component code: (b)(4) 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.Additional information was requested and the following was obtained: were there any unexpected outcomes or complications as a result of the prolonged surgery time? no further information is available.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain - no further information is available.Patient¿s current status? no further information is available.Could you please confirm how many devices presented the issue of needle pull off? no further information is available.How was the procedure completed? no further information is available.Device return status/follow up we regularly contact with sales rep about the device returning.No further information will be provided.Events reported in 2210968-2021-01652.
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass graft on (b)(6) 2021 and suture was used.During anastomosis by continuous suturing, the needle was detached from the suture.It was not a control release needle.The operation time was extended within 30 minutes.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 04/15/2021.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 analysis summary: visual analysis of the returned sample determined that twenty-four unopened samples of product code epm8738 were received for evaluation.Visual inspection of unopened samples was conducted and no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were observed.A functional test was performed using an instron and the pull force were above the minimum requirements.The device performed without any defect noted and the actual complaint sample was not received for evaluation.H6 component code: g07002 - device sample from same lot.A manufacturing record evaluation was performed for the finished device lot number qgbbdq /epm873819, and no non-conformances related to the reported complaint condition were identified.(b)(4).Date sent to fda: 04/15/2021.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: PRLNE BLU 2X18IN 8-0 D/A BV130-5 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11358325
• Report Number: 2210968-2021-01651
• Device Sequence Number: 19480633
• Product Code: GAW
• UDI-Device Identifier: 10705031218925
• UDI-Public: 10705031218925
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2021

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 Expiration Date: 05/31/2025
• Device Model Number: EPM8738
• Device Catalogue Number: EPM8738
• Device Lot Number: QGBBDQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 01/29/2021; 03/21/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 02/22/2021; 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1