MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y427H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
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.A manufacturing record evaluation was performed for the finished device lot number qkmcmt and no non-conformances related to the reported complaint condition were identified.(b)(4).Device not returned.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.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 name of the procedure? what was the procedure date? was there any adverse consequence associated with the patient? how was the suture placed (interrupted or continuous)? what is the surgeon expected time between the suture placement and the "absorption"? what, in the physician's opinion, are the factors contributing to the event? was re-suturing performed? how many sutures did not absorb? was any medical or surgical intervention provided to the patient for the sutures not being absorbed? device return status: note: events reported in 2210968-2021-06475, and 2210968-2021-06476.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Post-op, the suture was is not absorbing.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Date sent to the fda: 9/21/2021 h6 component code: g07002 - no device problem found.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, or its employees that the report constitutes an admission that the product, ethicon, 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.Investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that an opened box with twenty-one unopened samples of product code y427h were received for evaluation, the samples were examined for visual defects: ¿ appearance ¿ color package ¿ wrinkles in the seal area ¿ continuous seals ¿ seal margins ¿ over-sealing ¿ damage (torn, punctured) the packets were opened, and the swage and attachment area was noted to be as expected.During the visual inspection, the sutures were correctly placed on the paper folder.Sutures were dispensed without problems and examined along the strand and no defects, damage on the suture surface could be observed.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 quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed.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.

• Brand Name: MCRYL UD 27IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12195979
• Report Number: 2210968-2021-06474
• Device Sequence Number: 19738258
• Product Code: GAN
• UDI-Device Identifier: 10705031059153
• UDI-Public: 10705031059153
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K964072
• 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): 06/23/2021

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: 08/31/2025
• Device Model Number: Y427H
• Device Catalogue Number: Y427H
• Device Lot Number: QKMCMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1