MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 36"(90CM) 2-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Model Number VR917

Device Problems Break (1069); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).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.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.Related reports: 2210968-2022-02557, 2210968-2022-02558.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.It was reported that the needle tip was found blunt when sewing in unknown surgery and the suture broke.Changed another two to continue the surgery, the same problem happened.Changed another one to complete the surgery.There are no patient consequences reported.No additional information could be provided.

Manufacturer Narrative

Product complaint # (b)(4) date sent to the fda: 5/5/2022 additional information: d4, h3, h4, h6 h6 component code: c22 - photo analysis a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary - photo analysis: after visual inspection of the image sent to ethicon for evaluation.The suture appears to be damaged and extremely stressed.To avoid this type of damage: hold the needle in an area one-third (1/3) to one-half (1/2) of the distance from the end of the accessory to the tip.To avoid this type of damage: hold the needle in an area one-third (1/3) to one-half (1/2) of the distance from the end of the accessory to the tip.As part of our quality process, manufacturing records for this batch serial number were reviewed and manufacturing standards were met prior to the release of this batch.No conclusion could be reached on the cause of the reported complaint, as the sample was not returned for analysis.As part of ethicon's quality process, all devices are manufactured, inspected, and released to approved specifications.Additional information on complaints is tracked for potential safety signals through complaint trends as part of post-market surveillance.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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 8/15/2022.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that one opened box with twenty-four packets of product code vr917 was received to ethicon for evaluation.Upon initial inspection of the sample no external damages were observed on the box and packets.As per the sampling plan, a visual inspection was performed on thirteen samples, the samples were opened, and the swage and attachment area was noted to be as expected.The needles were intact and no damage, or breakage on the body, tip, or swage area was observed during the evaluation.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 using an instron and the tensile strength force was above the minimum requirement.The event described could not be confirmed as the device performed without any defect noted.In addition, the needles were observed to be within specification due to all of them belong to sales type v-34, tapercut and no damages could be observed during the visual inspection.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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: VICRYL RAPIDE SUTURE 36"(90CM) 2-0 UND
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14078953
• MDR Text Key: 298592516
• Report Number: 2210968-2022-02559
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031134768
• UDI-Public: 10705031134768
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2022

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
• Device Operator: Health Professional
• Device Model Number: VR917
• Device Catalogue Number: VR917
• Device Lot Number: AR2438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 04/13/2022; 08/01/2022
• Supplement Dates FDA Received: 05/06/2022; 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1