MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J840D
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.The following information was requested, but unavailable: - lot number.
Event or Problem Description
It was reported that a patient underwent a total knee replacement procedure on (b)(6) 2023 and suture was used.A surgical tech opened up a pack of suture and there was what appeared to be a black hair in the swage of the needle.The pack of suture was placed to the side of the field and a new pack of sutures was opened.There was no direct impact to patient or procedure and no needles or suture were removed from the pack.No delays.No fragments made.No patient harm.No further information was provided.
Additional Manufacturer Narrative
(b)(4).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 h3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that it was received one opened sample that pertain to the product code j840d.The product is a control release; each packet should contain eight strands.Upon initial inspection of the sample foreign matter (which appears to be a hair) was observed inside the attachment area on one needle.Based on the information currently available, the foreign matter was identified during the investigation of the samples received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.The manufacturing records couldn't be reviewed as the batch number is unknown.

• Brand Name: VCL CT BRD UD 8X18IN 0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18132162
• Report Number: 2210968-2023-08801
• Device Sequence Number: 18071352
• Product Code: GAM
• UDI-Device Identifier: 10705031043237
• UDI-Public: 10705031043237
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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 Catalogue Number: J840D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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