MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A404

Device Problem Component Missing (2306)

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

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Device analysis / photo analysis: visual analysis of the individual image received for evaluation determined that two open foil packages with product code sxpp1a404 and sxmd1b407 were apparently visible.Image is not clear to determine failure mode or reported condition.As with any device, care must be taken not to damage the thread when handling it.Avoid crushing or bending surgical instruments, such as needle holders and forceps.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 quality process, all devices are manufactured, inspected, and released to approved specifications.The product was returned for evaluation.Visual analysis of the returned product revealed that one opened sample product code sxpp1a404 was received for evaluation.Upon visual inspection of the returned sample, the suture barbs were to be damaged at the tips, in addition the fixation tab was observed to have two sides broken.After further evaluation of the fixation tab crimping marks were observed on the tab possibly from a surgical device.It should be noted that a 100% inspection is perform via automotive vision system to ensure the tab is present and complete during manufacturing.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.To seat the fixation tab; pull the device through the tissue to gently seat the fixation tab against the tissue.The fixation tab should be seated above the tissue plane and be visible.Do not exert additional force on the fixation tab.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 quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 g/m.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and barbed suture was used.Before use on patient, it was reported that the fixation feature had been missing in the newly dispensed suture when it was opened for an unknown surgery.Another like device was used to complete the surgery.Upon visual inspection of the returned sample, the suture barbs were to be damaged at the tips, in addition the fixation tab was observed to have two sides broken.After further evaluation of the fixation tab crimping marks were observed on the tab possibly from a surgical device.There were no patient consequences reported.No additional information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 2/14/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.H3 investigational summary: the product was returned to ethicon inc for evaluation.Ethicon inc conducted a visual inspection of the sample returned.Visual analysis of the returned product revealed that one opened sample product code sxpp1a404 was received for evaluation.Upon visual inspection of the returned sample, the suture barbs were to be damaged at the tips, in addition the fixation tab was observed to have two sides broken.After further evaluation of the fixation tab crimping marks were observed on the tab possibly from a surgical device.It should be noted that a 100% inspection is perform via automotive vision system to ensure the tab is present and complete during manufacturing.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.To seat the fixation tab; pull the device through the tissue to gently seat the fixation tab against the tissue.The fixation tab should be seated above the tissue plane and be visible.Do not exert additional force on the fixation tab.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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13055705
• MDR Text Key: 286922177
• Report Number: 2210968-2021-12837
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227699
• UDI-Public: 10705031227699
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K113004
• 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
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2022
• Device Model Number: SXPP1A404
• Device Catalogue Number: SXPP1A404
• Device Lot Number: QHMASR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2020
• 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