MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 1 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J261H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Inflammation (1932)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (b)(4) device not returned.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to receive additional information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Questions for patient #3: the patient demographic info: age, gender, weight, bmi at the time of index procedure? was the index procedure a total hip replacement? date of index procedure? on what tissues were vicryl sutures (j261h and j945h) used? product lot numbers for j261h and j945h? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how were both sutures placed (interrupted or continuous)? how were both sutures tied (square knot or multiple knots one end)? were any pre-op cleansing procedures or products changed recently? if yes, please describe.Did the operating surgeon observe any suture deficiency or anomaly before, during or after the suture placement? please specify.What tissue dehisced? was there any precipitating stress factor for the wound dehiscence? how was wound dehiscence managed? if a surgical intervention was performed: date and details of re-operation? what was the appearance of both sutures (j261h and j945h) during the second procedure? please explain what does it mean ¿but wound dehiscence didn't help¿? what medical intervention was performed to treat deep joint infection? results? other relevant patient factors/comorbidities/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2021-08608.
Event or Problem Description
It was reported that the patient underwent an elective tha procedure on unknown date and the suture was used.The patient experienced post-op inflammation at the suture site.The patient also had wound dehiscence 2-3 months post op and has been treated for deep joint infection x2.The surgeon opined that doubt if deep infection related to suture as patient has a history of iddm and previous joint sepsis additional information has been requested.

• Brand Name: VCL CT BRD UD 27IN 1 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12489450
• Report Number: 2210968-2021-08609
• Device Sequence Number: 17229771
• Product Code: GAM
• UDI-Device Identifier: 10705031038356
• UDI-Public: 10705031038356
• 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
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2021

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: J261H
• Device Catalogue Number: J261H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 09/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention