MAUDE Adverse Event Report: TRILLIANT SURGICAL; MINIMALLY INVASIVE BUNION PLATING SYSTEM PLATE

Device Problems Off-Label Use (1494); Biocompatibility (2886)

Patient Problem Deformity/ Disfigurement (2360)

Event Type  Injury  

Manufacturer Narrative

Notes to form 3500a and justification for information not provided as required per 21cfr803.52 is below.Trilliant surgical attempted to obtain the omitted information (items 1-13 below) as part of internal complaint handling activities.Patient age at time of event, date of birth , and weight not reported.Date of event is unknown.The event is considered to be the bunion reocurrence.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Brand name, model #, lot # and unique identifier (udi) # are unknown.Implanted date is estimated as (b)(6) 2019 as it was reported to be (b)(6) 2019.Concomitant medical products and therapy dates not reported.Initial reporter fax not reported.Device bla number is n/a to this report.Na was not entered within this field as this caused technical errors to occur in previous mdr submissions.Device manufacture date is unknown.Investigation: evaluation of similar complaints: the complaints log was reviewed to identify any similar events involving bunion reocurrence between (b)(6) 2019 and (b)(6) 2020.One (1) similar complaint was identified with an unknown root cause: (b)(6).This event cannot be confirmed to contain parts of the same lot number as the reported event as the lot number for the reported event is unknown.Device history record (dhr) review: dhr review was not conducted as part / lot number(s) are unknown or could not be narrowed down.The sales representative was unable to provide information surrounding the original implantation of the mib construct.Thus, the part number and associated lot numbers were unknown and dhr review could not be conducted.Review of surgical technique: minimally invasive bunion plating system instructions for use, ifu 900-01-016 revision d corresponds to the event.It is documented that the doctor/ user did not follow the ifu.It is noteworthy that the patient is a diabetic, which is a metabolic disease.There is a contraindication within the ifu for "patients with certain metabolic diseases".Thus, the doctor is expected to have utilized reasonable judgement to evaluate the risk he was willing to take when utilizing the mib plating system on his patient with diabetes.Visual and dimensional inspection: no parts were returned, so visual and dimensional inspection could not be conducted.Simulated use testing: it is noted on the customer complaint report activity log, frm (b)(4), that the sales representative reported the "patient was in bad health and middle aged and the construct failed most likely because of the patient's body working against him." based on the limited information provided and confirmation that the patient is a diabetic, simulated use testing could not be performed in attempt to recreate the event.Investigation conclusion: (b)(4) was identified as a similar complaint.However, the root cause of (b)(4) was unknown and does not provide insight into this investigation for (b)(4).Within the "description of incident / event" on customer complaint report (ccr) information and evaluation, frm (b)(4), it is documented that the patient had an intermetatarsal angle of 12 degrees, indicating that the patient had a mild bunion.No x-rays are available to review the severity of the bunion reoccurrence or to evaluate if fusion had occurred following implantation of the mib plating system hardware.It is also documented that the patient was a diabetic, which is a metabolic disease.Utilizing the mib plating system hardware on a patient with a metabolic disease is a contraindication per minimally invasive bunion plating system instructions for use, ifu 900-01-016 revision d.It is noted on the customer complaint report activity log, frm (b)(4), that the sales representative reported the "patient was in bad health and middle aged and the construct failed most likely because of the patient's body working against him." the information available is limited.However, based on the information provided by the sales representative and the contraindication pertaining to patients with metabolic disease, the root cause shall be to failure to follow the ifu.

Event Description

On (b)(6) 2020, a trilliant surgical sales representative reported the removal of a minimally invasive bunion (mib) construct due to bunion reoccurrence.The removal was performed by doctor 1 at hospital x on (b)(6) 2020.Information regarding the original implantation of the mib construct is unknown at this point with the exception of the construct being implanted roughly a year prior.The patient information is unknown at this time with the exception that the patient had an intermetatarsal (im) angle of 12 degrees, a mild bunion prior to correction, and was diabetic.The sales representative was sent an email (outlined below) following the report to see if he could obtain the missing information."hey [sales representative], if you could obtain the following information for me from dr.[x] regarding the revision case on (b)(6) 2020 and the original implantation of the mib construct that would be amazing.If you cannot gather the following please let me know by responding to this email after best efforts were made! can you provide x-rays at the following times? upon mib construct implantation showing the original correction.At the time the bunion reoccurrence was seen.Upon completion of the revision case on (b)(6) 2020.Date dr.[x] saw reoccurrence and decided on surgical intervention.Date the mib construct was originally implanted.Facility the mib construct was originally implanted at.Patient gender.Patient date of birth.Patient weight.Do any of the following apply to the patient: smoker, diabetic, osteoporosis, allergies." the removal that occurred on (b)(6) 2020 removed the previously implanted mib construct in order to revise by fusing the metatarsophalangeal joint.The revision was completed with integra product and the utilization of vibone as filler.The plate and associated screws were disposed of following the procedure and will not be returned to trilliant surgical's corporate office for further investigation.

• Brand Name: UNK
• Type of Device: MINIMALLY INVASIVE BUNION PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston TX 77007 1320
• Manufacturer (Section G): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston TX 77007 1320
• Manufacturer Contact: sofia middleton ; 727 north shepherd drive; suite 100; houston, TX 77007-1320 ; 7133886063
• MDR Report Key: 10736088
• MDR Text Key: 216677289
• Report Number: 3007420745-2020-00046
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention