MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J259H
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).This information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Note: events reported via mw # 2210968-2021-01748, 2210968-2021-01749.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke while the surgeon was trying to tie a knot.There were no adverse patient consequences.
Additional Manufacturer Narrative
Date sent to the fda: 03/23/2021.Additional information: d4, d9, h4, h6.A manufacturing record evaluation was performed for the finished device lot number qlmkzz /j259h06, and no non-conformances related to the reported complaint condition were identified.Additional h-3 summary: visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that a suture piece and a labeled winding former of product code j259 were received for evaluation and body fluids, damaged on the surface and the ends were noted cut appear to be by use of the surgical instrument and the functional test could not be performed due to condition of the sample.The condition of the sample received indicates improper handling of the device.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.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: VCL CT BRD UD 27IN 2-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11372619
• Report Number: 2210968-2021-01748
• Device Sequence Number: 13631972
• Product Code: GAM
• UDI-Device Identifier: 10705031038318
• UDI-Public: 10705031038318
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• 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): 02/01/2021

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: J259H
• Device Catalogue Number: J259H
• Device Lot Number: QLMKZZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1