MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A OS-6; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Fever (1858); Nausea (1970); Pain (1994); Chills (2191); Dizziness (2194)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name: irgacare®.Active ingredient(s): triclosan.Dosage form: suture/solid/parenteral.Strength: = 2360 g/m.Note: events reported on mw# 2210968-2021-09478 and mw# 2210968-2021-09480.(b)(4).Additional information: home nurse: on (b)(6) 2021 [po # 3] nurse: opov withdrawal, no flow.Instructions that he can shower without direct jet on the surgical site and dry well.On (b)(6) 2021 [po # 6] physio: mild heat right hip (inflammatory type) no discharge, no redness.On (b)(6) 2021 [po # 12] nurse: adhesive withdrawal.Dried blood crusted along the wound.No redness, no discharge, no sign of infection.Adhesion of wound edges.On (b)(6) 2021 [po # 15] physio, no redness, no discharge, no dehiscence.Moderate adhesion all along the wound.On (b)(6) 2021 [po # 19] telephone call nurse r / a adhesive withdrawal: wound edges open upper extremity with ventral fatty folds.Redness + edema + discharge for 3 days.Transfer to routine care in order to assess.On (b)(6) 2021 (revision po # 14) nurse: removal of staples (according to surgical report: points to close), wound dehiscence in superior.On (b)(6) 2021 wound healed.Post revision microbiology monitoring: on (b)(6) 2021: ancef j9, wound closed and threads in place.On (b)(6) 2021: ancef j16, rifampin j7, persistence of flow from the upper portion of the wound to be monitored.On (b)(6) 2021: ancef j23 rifampin j14, persistence of upper and lower sero-blood flow.No redness.On (b)(6) 2021: ancef j30, rifampin j21, persistent flow but point found and removed.On (b)(6) 2021: ancef j37, rifampin j28, good development, flow stopped.On (b)(6) 2021: ancef iv ceased, addition of levofloxacin + rifampin po continued.On (b)(6) 2021: antiobio ceased post-revision ortho follow-up: 2021-04-30, 2021-05-10, 2021-05-21, 2021-06-14, 2021-09-10 -> see again in 12 months.According to the various notes read, the user seems to respect the instructions given in connection with hygiene care and asepsis around the care of his wound and the use of his iv.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Was prineo and/or stratafix used during the revision surgery? if so please provide which products were used and on which tissue layer.Did the wound dehisce after the initial procedure? did the wound dehisce after the revision surgery? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what is the physician¿s opinion as to the etiology of or contributing factors to this event? surgeon¿s name? lot numbers? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? how much and what type of drainage is present in this wound? please describe how was the adhesive was applied? on what tissue was the suture used/location of suture placement? what tissue dehisced? what was the tissue condition (normal, thin, calcified, fragile, diseased)? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure.Were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? no product is available for return.

Event Description

It was reported a patient underwent a right anterior total hip arthroplasty on (b)(6) 2021 and barbed suture was used.On (b)(6) 2021 (post op day # 24) patient went to emergency visit.Patient had onset redness and pain when walking, temperature x 24 hours, chills, nausea, dizziness.Superficial pus: staph aureus in the wound, with abscess, wound dehiscence at the upper point since surgery on (b)(6) 2021 patient was hospitalized.Revision surgery: debridement / washing and change of liner and femoral head.Closure with staples / mepilex.Follow-up with microbio and aaiv [ancef iv then addition of rifampin po].Additional information has been requested.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A OS-6
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12608081
• MDR Text Key: 279832620
• Report Number: 2210968-2021-09479
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227705
• UDI-Public: 10705031227705
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPP1A201
• Device Catalogue Number: SXPP1A201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 101