MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J494H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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, and no non-conformances were identified.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.Investigation summary: visual analysis of image submitted for evaluation determined that a winding former could be observed with one apparently detached from product code j494h, image not clear to determine failure mode.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.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.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.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.Additional information was requested and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Female, (b)(6), normal bmi.Date and name of index surgical procedure? (b)(6) 2022.Lot number? rjmbam.The diagnosis and indication for the index surgical procedure? compound dysplastic nevus with mod atypia, + margins.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? cutaneous.On what tissue was the suture used? dermis, sq.What was the tissue condition (normal, thin, calcified, fragile, diseased)? normal.How was the suture placed (interrupted or continuous)? interrupted.After the needle pulled off the suture and fell into the patient, was the needle removed during that initial surgery? yes.Was a second procedure required to remove the needle? no.Does the needle remain retained in the patient as the current time? na.If yes, what structure is the needle located in? na.If yes, are there plans to remove the needle at a later time? na.Please describe any medical/surgical intervention required for this suture event including dates and results.Na.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? defective suture.What is the patient's current status? alive and well.If applicable, will product or representative samples be returned? if so, please provide the name and address of where the samples are located and a mailer can be sent.
Event or Problem Description
It was reported that a patient underwent an elliptical excision of a nevus on (b)(6) 2022 and suture was used.During the procedure, the needle came off the suture.The needle that fell into the patient was removed from the patient during that same procedure.The current condition of the patient was reported as well.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VCL CT BRD UD 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13839103
• Report Number: 2210968-2022-01961
• Device Sequence Number: 884286
• Product Code: GAM
• UDI-Device Identifier: 10705031040533
• UDI-Public: 10705031040533
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2022

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: 07/31/2026
• Device Model Number: J494H
• Device Catalogue Number: J494H
• Device Lot Number: RJMBAM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 64 KG