MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2MH -0- PDO 24 X 24

Model Number SXPD2B408

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Blister (4537)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

No sterile samples were returned from the initial lot for testing/review.No retained samples were available for review.A photo of the post-operative incision was provided for review.The incision appeared to be healing as intended.Blistering was observed alongside the incision line; large darkened blisters were present.The surgeon noted the patient has not been very mobile.The surgeon also stated he has seen similar skin reactions when patients place ice packs directly on skin for too long.Potential for skin reactions where dermabond prineo system is utilized:there is potential for patients to experience skin reactions (e.G., redness, itchy rashes, or blisters) as noted in the instructions for use.Patients with sensitivities to benzalkonium chloride, formaldehyde, or cyanoacrylate adhesives (i.E., cosmetic adhesives used to attach false eyelashes or fingernails, adhesives used in crafting) or to pressure-sensitive adhesives (i.E., bandages or tapes) could be predisposed to similar reactions to dermabond prineo system.Healing or complications can occur post-operative any surgical procedure if strict asepsis is not maintained throughout the procedure and post-operative, if the wound edges are not aligned properly or if sutures are too tight.This can lead to devitalisation of the tissue at the wound, post-operative discomfort and healing issues.Healing of the incision site can also be affected if the patient has other health problems that can hinder or prolong the healing process (ex.Diabetes, heart or circulatory problems, allergic to the suture material and/or pain meds).Without reviewing and testing devices from the same finished good lot or receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, patient¿s pre-existing health conditions/allergies, post-operative instructions or events that may have occurred and/or contributed to the condition reported or the surgeon's technique, a definitive root cause cannot be determined at this time.

Event Description

It was reported by the rep.During a tka procedure on (b)(6) 2021, dermabond prineo 42 (clr422us) was applied to the knee.The knee capsule was approximated and closed with interrupted vicryl and sxpd2b405.Subcutaneous was closed with interrupted vicryl.Subcuticular was closed with sxpd2b408.The knee was put in full flexion, and clr422us was applied following ifu.On (b)(6), the surgeon informed rep of blistering near prineo site.The surgeon shared a photo with the rep.The surgeon stated the patient has not been very mobile.The surgeon stated he has seen similar skin reactions when patients place ice packs directly on skin for too long.I certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.

Manufacturer Narrative

Follow-up information including pictures were received and reviewed by ethicon¿s medical safety officers: the photo reveals a vertical wound of the right knee with the prineo mesh attached.The wound is well-approximated however there is erythema the length of the wound emanating from the mesh throughout.There are also multiple areas of large scabbing, also emanating from the mesh edges, likely secondary to blistering.This can be consistent with contact dermatitis.As of (b)(6) 2021, patient still recovering, most blisters except one have subsided, patient not following physical therapy regiment.As of (b)(6) 2021: product not removed, no re-operation, no re-closure.

• Brand Name: STRATAFIX
• Type of Device: 2MH -0- PDO 24 X 24
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 12487725
• MDR Text Key: 271888894
• Report Number: 3010692967-2021-00039
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPD2B408
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention