MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 8-0 D/A BV175-6 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8743
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc-(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The following information was requested but unavailable: procedure and event date? attempts are being 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.
Event or Problem Description
It was reported that the patient underwent an unknown cardiovascular surgery on an unknown date and suture was used.The suture was broken during use.There were no adverse consequences to the patient.
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.Additional information: h3 analysis summary: the product was returned to ethicon inc for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that a suture piece of product code epm8743 was received for evaluation body fluids and crushed on the surface suture was noted and an end is fraying and the other was noted cut appears to be by use of the surgical instrument and the functional test could not be performed due to condition of the sample.The condition of the sample received indicates improper handling of the device.The manufacturing records couldn¿t be reviewed as the batch number is unknown.(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 2X24IN 8-0 D/A BV175-6 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11379894
• Report Number: 2210968-2021-01797
• Device Sequence Number: 3786308
• Product Code: GAW
• UDI-Device Identifier: 10705031206748
• UDI-Public: 10705031206748
• 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
• Report Date (Section B): 02/10/2021

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 Model Number: EPM8743
• Device Catalogue Number: EPM8743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/15/2021
• Patient Sequence Number: 1