MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A CC MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8704
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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: was the needle removed from the patient during the same procedure? yes how many suture needle were pull off during suturing on this one patient during this single surgical procedure? unknown what tissue/location was suturing when pull off occurred? unknown were there any unexpected outcomes or complications as a result of this suture needle pull off event? unknown the single complaint was reported with multiple events.There are no additional details regarding the additional events.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: three opened boxes with twelve, eleven and five packets on each box of product code m8741 were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the eighteen packets.No product from product code m8704 was received for evaluation.In order to evaluate the conditions of the returned samples, thirteen packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand to detect any issue related to damaged and no defects were observed during evaluation.A functional test was performed and the pull force 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.This report is not intended to deny that you experienced a problem with the device.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Device history lot: a manufacturing record evaluation was performed for the finished device lot number qlbajd / m874119, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
It was reported that a patient underwent a surgical procedure on (b)(6) 2021 and suture was used.The needle popped off extremely easy when trying to use.This suture is used for anastomosis of saphenous vein to coronary artery - many passes through tissues are required.There were no patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 4X24IN 7-0 D/A CC MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12055713
• Report Number: 2210968-2021-05784
• Device Sequence Number: 3705013
• Product Code: GAW
• UDI-Device Identifier: 10705031045798
• UDI-Public: 10705031045798
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/28/2021

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: 09/30/2025
• Device Model Number: M8704
• Device Catalogue Number: M8704
• Device Lot Number: QMBCXM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/16/2021
• Patient Sequence Number: 1