MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 8-0 D/A BV175-6 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	D8292
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.How many sutures broke? how many minutes was the procedure delayed? was there any patient consequences? lot 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.
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass (b)(6) 2020 and suture was used.During the procedure, the suture broke.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/26/2021.Additional h3 investigation summary: an empty opened folder and two sutures pieces of product code d8292, were received for evaluation.This product is double armed.During the visual inspection of two needle/suture pieces, the swage and attachment area were noted to be as expected, the suture ends were observed with damaged, elongation and detached due to stress applied.They coincide with each other.The condition of the sample received indicate an improper handling of the device.The manufacturing records couldn't be reviewed as the batch number is unknown.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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 Manufacturer Narrative
(b)(4).Date sent to the fda: 2/16/2021.Additional information was requested and the following was obtained: how many sutures broke? 1.How many minutes was the procedure delayed? no procedure delay is reported.Was there any patient consequences? there were no adverse consequences to the patient.Lot no further information is available.No further information will be provided.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 30IN 8-0 D/A BV175-6 MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11016279
• Report Number: 2210968-2020-09962
• Device Sequence Number: 3595160
• Product Code: GAW
• UDI-Device Identifier: 10705031029767
• UDI-Public: 10705031029767
• 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): 11/26/2020

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: D8292
• Device Catalogue Number: D8292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 01/05/2021; 01/27/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/26/2021; 02/16/2021
• Patient Sequence Number: 1