MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP352H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an open reduction and internal fixation of humeral fracture procedure on (b)(6) 2021 and suture was used.Before use on patient, it was reported that the problem of pulling off suture needle had happened in the newly dispensed suture when it was opened to prepare for surgery.Upon evaluation of the returned sample, a short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was found detached since the insertion end of the suture did not meet the requirement.The defect is caused because the suture was not properly inserted inside of the needle barrel hole resulting in a pull-out defect.Another like device was used to complete the surgery.No adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Photo analysis: visual analysis of the received image determined that a winding former with a detached needle of product code (b)(4) could be observed in a plastic bag, the image is not clear to determine the failure mode.To avoid this type of damage: hold the needle in an area one-third (1/3) to one-half (1/2) the distance from the end of the accessory to the tip.As part of our quality process, manufacturing records for the serial number of this batch were reviewed and manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to the cause of the reported complaint as the sample was not returned for testing.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure it meets the required specifications prior to shipment.Sample analysis: visual analysis of the returned sample revealed that one sample of product code (b)(4) was received to for evaluation.After investigation of the sample, short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was found detached since the insertion end of the suture did not meet the requirement.The defect is caused because the suture was not properly inserted inside of the needle barrel hole resulting in a pull-out defect.Based on the information currently available, the pull-out was identified during the investigation of the sample received.This product issue will be addressed through quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 ¿g/m.
Event or Problem Description
It was reported that a patient underwent an open reduction and internal fixation of humeral fracture procedure on (b)(6) 2021 and suture was used.Before use on patient, it was reported that the problem of pulling off suture needle had happened in the newly dispensed suture when it was opened to prepare for surgery.Upon evaluation of the returned sample, a short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was found detached since the insertion end of the suture did not meet the requirement.The defect is caused because the suture was not properly inserted inside of the needle barrel hole resulting in a pull-out defect.Another like device was used to complete the surgery.No adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Photo analysis: visual analysis of the received image determined that a winding former with a detached needle of product code (b)(4) could be observed in a plastic bag, the image is not clear to determine the failure mode.To avoid this type of damage: hold the needle in an area one-third (1/3) to one-half (1/2) the distance from the end of the accessory to the tip.As part of our quality process, manufacturing records for the serial number of this batch were reviewed and manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to the cause of the reported complaint as the sample was not returned for testing.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure it meets the required specifications prior to shipment.Sample analysis: visual analysis of the returned sample revealed that one sample of product code (b)(4) was received to for evaluation.After investigation of the sample, short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was found detached since the insertion end of the suture did not meet the requirement.The defect is caused because the suture was not properly inserted inside of the needle barrel hole resulting in a pull-out defect.Based on the information currently available, the pull-out was identified during the investigation of the sample received.This product issue will be addressed through quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 ¿g/m.

• Brand Name: VCL+ VIO 27IN 0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905 4403
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13585707
• Report Number: 2210968-2022-01248
• Device Sequence Number: 12182796
• Product Code: GAM
• UDI-Device Identifier: 10705031052635
• UDI-Public: 10705031052635
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: VCP352H
• Device Catalogue Number: VCP352H
• Device Lot Number: PJ4475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown