MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 0 S/A CTXB CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	JB724
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on an unknown date and a suture was used.During the procedure, the suture pulled off the needle.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 02/09/2021.Additional information was requested, and the following was obtained: this event was reported with (b)(4) suture involved but we received (b)(4) additional used needles without sutures, please clarify: were extra (b)(4) returned cr needles affected with the same issue, pull off during this unknown procedure.It is supposed that one of them is the affected product.However, we cannot identify which one is the affected product.No further information will be provided.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 Manufacturer Narrative
Date sent to the fda: 02/08/2021 additional information: d9, h6 additional h6 component code: g07002 ¿ conforming device additional h-3 summary: rep sample: a paper lid and a winding former with a needle/suture combination of product were received for evaluation.During the visual inspection of sample, the swage and attachment area were noted to be as expected.The suture was received dispensed and no damaged could be noted.A functional test was performed using an instron and the pull force were meet the customer requirements.The manufacturing records couldn't be reviewed as the batch number is unknown.6 cr needles returned, same evaluation narrative: a used needle of product was received for evaluation.During the visual inspection of a detached needle, the swage and attachment area were noted to be as expected, marks by use of surgical instrument were noted on body needle.The suture was not received to determine the assignable cause and no functional tests could be performed.The manufacturing records couldn't be reviewed as the batch number is unknown.No conclusion could be reached as the needles of the box pulled off.Attempts are being made to clarify 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.This event was reported with 1 suture involved but we received 6 additional used needles without sutures, please clarify: were extra 6 returned cr needles affected with the same issue ¿ pull off during this unknown procedure? 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 8X18IN 0 S/A CTXB CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11066451
• Report Number: 2210968-2020-10259
• Device Sequence Number: 1193231
• Product Code: GAM
• UDI-Device Identifier: 10705031043954
• UDI-Public: 10705031043954
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2020

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: No Information
• Device Model Number: JB724
• Device Catalogue Number: JB724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/13/2021; 02/08/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/08/2021; 02/09/2021
• Patient Sequence Number: 1