MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 5-0 S/A TF; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y433H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
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.The following information was requested, but unavailable: were there any unexpected outcomes or complications as a result of the prolonged surgery time? was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain.No further information is available.Attempts are being 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.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a ventriculoperitoneal shunt surgery on (b)(6) 2021 and suture was used.The suture detached from the needle during dermostitch.It was not a control release needle.The operation time was extended within 30 minutes.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Date sent to the fda: 7/13/2021 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 h3 investigation summary: h3 investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.An empty opened foil, a paper lid and a detached needle of product code y433h were received for analysis.In order to evaluate the conditions of the returned samples the swage and attachment area were noted to be as expected, no marks or suture remnant could be observed in the needle.The suture was not received for evaluation to determine the assignable cause.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.No conclusion could be reached as to what caused the reported complaint.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.

• Brand Name: MCRYL UD 27IN 5-0 S/A TF
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11982932
• Report Number: 2210968-2021-05455
• Device Sequence Number: 13724610
• Product Code: GAN
• UDI-Device Identifier: 10705031059184
• UDI-Public: 10705031059184
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/17/2021

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: 06/30/2025
• Device Model Number: Y433H
• Device Catalogue Number: Y433H
• Device Lot Number: QHMKJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 07/13/2021
• Patient Sequence Number: 1