MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J269H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Erythema (1840); Impaired Healing (2378)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch qcmcsh; expiration date: 2/28/2025.Date of mfg.: 3/9/2020.Batch pl6971; expiration date: 9/30/2024.Date of mfg.: 10/16/2019.A manufacturing record evaluation was performed for the finished device qcmcsh possible batch number and finished device pl6971 possible batch number, and no non-conformances were identified.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.Additional information was requested and the following was obtained: left knee arthroscopy with patella tendon autograft acl reconstruction, partial lateral meniscectomy.Dos: (b)(6) 2020.Patient reported wound healing about 6 weeks postoperatively via telephone.He was started on oral antibiotics.Follow-up appointment on (b)(6) 2020 showed left knee incision healing with the exception of 2 small areas with some mild superficial erythema and a small stitch abscess.Patient advised to continue the antibiotics.Notes - patient is young and healthy.Virgin skin.Not expected to have wound issues.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info for patient ¿al¿: age, weight, bmi at the time of index procedure.The diagnosis and indication for the index surgical procedure? on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? please describe the wound healing issue described by the patient 6 weeks post-op? have any pre-op cleansing procedures or products changed recently? did the patient experience an infection? if yes, were cultures performed? results? other relevant patient history/concomitant medication what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.
Event or Problem Description
It was reported that the patient underwent left knee arthroscopy with patella tendon autograft acl reconstruction, partial lateral meniscectomy on (b)(6) 2020 and suture was used.About six weeks post-op, the patient reported wound healing via telephone and the patient was started on oral antibiotics.On (b)(6) 2020 follow-up appointment, the patient showed left knee incision healing with the exception of two small areas with some mild superficial erythema and a small stitch abscess.The patient was advised to continue with antibiotics.It was reported the patient is young, healthy and not expected to have wound issues.Additional information has been requested.

• Brand Name: VCL CT BRD UD 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10465226
• Report Number: 2210968-2020-06461
• Device Sequence Number: 16924211
• Product Code: GAM
• UDI-Device Identifier: 10705031038431
• UDI-Public: 10705031038431
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: J269H
• Device Catalogue Number: J269H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention