MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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.Investigation summary: an opened box with ten packets of product code epm8702 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 ten 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 were 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.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch, and no non-conformance's were identified.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 was the procedure date? what was used to complete the procedure? in relation to needle, what is the approximate location of suture breakage? did the suture separate completely? what tissue was being approximated or sutured when it broke? was there any adverse consequence associated with the patient? events reported via: 2210968-2021-07189.
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2021 and suture was used.During the procedure, the suture broke.The surgeon opined that the suture looked frayed or almost "crystallized" in appearance where it broke.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 9/14/2021.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 h6 component code: g07002 reported condition not confirmed.Additional h3 investigation summary.An opened box with twelve packets of product code epm8702 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 twelve 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 were 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 4X24IN 7-0 D/A BV-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12303388
• Report Number: 2210968-2021-07188
• Device Sequence Number: 12036394
• Product Code: GAW
• UDI-Device Identifier: 10705031134805
• UDI-Public: 10705031134805
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2021

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: 03/31/2026
• Device Model Number: EPM8702
• Device Catalogue Number: EPM8702
• Device Lot Number: RDBBZT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 07/17/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1