MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X30IN 6-0 D/A C-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8706
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.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.What is the lot number? how long was the surgery delayed? was the re-suturing performed during the same surgery?.
Event or Problem Description
It was reported that a patient underwent a cabg surgery on (b)(6) 2021 and suture was used.During the procedure, the suture broke when tying.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 09/28/2021.Additional information was requested, and the following was obtained: patient consequence from this was significantly extended or time.Since multiple sutures broke after all the stitches were placed, the surgeon was quite frustrated.Vessel anastomosis at this stage of the cabg is time consuming.Having to re-sew all those small stitches took quite a while.4 different suture breakages according to the dr.No altering of patient care due to the suture breakage.Patient is recovering today.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
Pc-(b)(4).Date sent to the fda: 8/31/2021 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: h6 patient code additional information: surgery was completed during the original procedure but delayed procedure by at least 15 min.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.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? what is the patient¿s current status?.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 8/31/2021.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.A manufacturing record evaluation was performed for the finished device lot number rbbddc and no non-conformances related to the reported complaint condition were identified.Additional h6 component code: g07002 reported condition not confirmed.Additional h3 investigation summary: an opened box with nine packets of product code epm8706 was returned for analysis with the packaging closed.Upon initial inspection of the samples, no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, the nine packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to damaged or breakage sutures and no defects were observed during evaluation.Functional test was performed, and the tensile strength result was above the minimum requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: PRLNE BLU 4X30IN 6-0 D/A C-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12232127
• Report Number: 2210968-2021-06717
• Device Sequence Number: 4301697
• Product Code: GAW
• UDI-Device Identifier: 10705031206854
• UDI-Public: 10705031206854
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/30/2021

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: 01/31/2026
• Device Model Number: EPM8706
• Device Catalogue Number: EPM8706
• Device Lot Number: RBBDDC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/31/2021; 08/31/2021; 09/01/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/31/2021; 08/31/2021; 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1