MAUDE Adverse Event Report: ETHICON INC. VCL RAP UD 18IN 5-0 S/A P-3 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VR493
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Events reported in 2210968-2021-02651.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.Attempts are being made to obtain 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.What tissue was being approximated or sutured when it broke? could you please provide lot number? please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.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 a pyeloplasty procedure on (b)(6) 2021 and suture was used.During the procedure, the suture snapped while pulling through tissue.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/20/2021.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 information: h6.H6 component code: g07002 reported condition not confirmed.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned samples determined that an empty opened box, two empty opened foils and five unopened samples of product code vr493 were received for evaluation.Visual inspection of the unopened samples, the swage, and the attachment area were noted to be as expected.The sutures were dispensed without problems and 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.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.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.The device performed without any defect noted.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/19/2021.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.A manufacturing record evaluation was performed for the finished device lot number an9122, and no non conformances / manufacturing irregularities were identified.H6 component code: g07002 - device evaluation pending.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4).Date sent to the fda: 4/19/2021.

• Brand Name: VCL RAP UD 18IN 5-0 S/A P-3 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11560413
• Report Number: 2210968-2021-02652
• Device Sequence Number: 17363923
• Product Code: GAM
• UDI-Device Identifier: 10705031134676
• UDI-Public: 10705031134676
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K033746
• 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,Followup
• Report Date (Section B): 03/04/2021

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: 08/31/2025
• Device Model Number: VR493
• Device Catalogue Number: VR493
• Device Lot Number: AN9122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/24/2021; 04/19/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/19/2021; 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1