MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 4X18IN 2-0 S/A UR-6 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	D9142
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 the following information was requested, but unavailable: please provide the lot number for the involved device.No further information is available.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on (b)(6) 2021 and suture was used.During the procedure, the suture was broken during use.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Date sent to the fda: 04/16/2021.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.Investigation summary : according to the information received, it was reported by a sales rep that, during an unknown surgery, the suture was broken during use.The product was returned to ethicon inc for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that a dispensed needle-suture of product code d9142 was received for evaluation.Upon visual inspection of the sample the swage and attachment area were noted to be as expected.The suture was examined along the strand and no defects, damage or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records couldn¿t be reviewed as the batch number is unknown.The device performed without any defect noted.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.The product was returned to ethicon inc for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that a needle-suture piece and three detached needles of product code d9142 were received for evaluation.The product code is a control release and contains eight strands per packet.Upon visual inspection of the sample, the swage and attachment area was noted to be as expected in the detached needles and the needle suture piece.The suture was examined along the strand and the end was observed cut appears to be by use of the surgical instrument.Additionally, a functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records couldn¿t be reviewed as the batch number is unknown.The device performed without any defect noted.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL CT BRD VIO 4X18IN 2-0 S/A UR-6 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11426659
• Report Number: 2210968-2021-02047
• Device Sequence Number: 2843553
• Product Code: GAM
• UDI-Device Identifier: 10705031032163
• UDI-Public: 10705031032163
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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 Model Number: D9142
• Device Catalogue Number: D9142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1