MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 4-0 S/A RB-1; SUTURE, ABSORBABLE, NATURAL

Model Number	U203H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(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: were the other incidents reported, please provide pc numbers? for this specific events how many sutures pull off from the needle? procedure.Only one incident occurred on one suture so they had to pull the entire box for safety reasons.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown surgery in 2021 and suture was used.During the procedure, the suture got detached from the needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 04/02/2021.Additional information: d9, h6 additional h6 component code: g07002 ¿ reported condition not confirmed.A manufacturing record evaluation was performed for the finished device lot number ppmhlc, and no non-conformances related to the reported complaint condition were identified.Additional h-3 summary: visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that thirty unopened samples of product code u203h were received for evaluation.Visual inspection of unopened samples and no defects were found on the package.The samples were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects or damage were observed.A functional test was performed and the pull force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted and the complaint sample was not received for evaluation.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.Date sent to the fda: 04/02/2021.Corrected information: d3, g1.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.

• Brand Name: GUT CHR UD 27IN 4-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11396860
• Report Number: 2210968-2021-01878
• Device Sequence Number: 11543455
• Product Code: GAL
• UDI-Device Identifier: 10705031051133
• UDI-Public: 10705031051133
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K946173
• 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): 02/05/2021

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: 11/30/2024
• Device Model Number: U203H
• Device Catalogue Number: U203H
• Device Lot Number: PPMHLC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/02/2021
• Patient Sequence Number: 1