MAUDE Adverse Event Report: TRILLIANT SURGICAL

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

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 when the patient began to experience pain.Brand name, common device name, model #, lot #, and unique identifier are unknown.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Implanted date is unknown.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 the field for bla number as this caused technical errors to occur in previous mdr submissions.Device manufacture date is unknown.Investigation (including evaluation summary) -evaluation of similar complaints the complaints log was reviewed to identify any similar events related to an mib removal between august2020 and august 2021.Eleven (11) similar complaints were identified.Of these 11 identified complaints, the root causes were as follows: failure to follow ifu, patient anatomy, patient noncompliance, unknown (6) and tbd (2).None of these related events were confirmed to contain parts from the same lot number(s) as the reported event as the part/lot numbers are unknown.Device history record (dhr) review: part / lot number(s) unknown or could not be narrowed down.With the information available and provided by the reporter, part numbers and lot numbers were unable to be identified.Thus, dhr review was unable to occur.Review of surgical technique: minimally invasive bunion plating system instructions for use, ifu 900-01-016 revision d, corresponds to the event.Limited information was provided for the surgical technique / conformance to the ifu so it is unknown if the doctor/ user followed the ifu.Visual and dimensional inspection: the parts were not returned, so no visual or dimensional inspection could be conducted.Simulated use testing: simulated use testing was not conducted for either returned device(s) nor with similar parts.With limited information available and the limitations of simulated use testing (i.E., unable to recreate "prominent painful hardware"), simulated use testing did not occur.Investigation conclusion: the similar complaints did not provide further insight into the evaluation of the root cause for the reported event.Dhr review could not be conducted.It is unknown if the surgeon followed the ifu and / or if the patient was compliant to post-operative instructions.The parts were not returned.Thus, inspection did not occur.Simulated use testing did not occur.As limited information is available, the root cause remains unknown at this time.

Event Description

On (b)(6) 2021, a scrub technician from hospital 1 contacted the djo foot & ankle sales support manager to request a minimally invasive bunion (mib) removal kit for an mib construct previously implanted.The patient requested the removal due to prominent painful hardware at the surgical site.The removal surgery will take place at hospital 1 by doctor 1 and was originally scheduled for (b)(6) 2021, but has now been rescheduled to (b)(6) 2021.The original implantation of the mib construct was by doctor 1 as well.The above details are all that is known for the report at this time and a follow up will occur with the scrub technician post-removal.

• Brand Name: UNK
• Type of Device: UNK
• 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: 12386513
• MDR Text Key: 268906403
• Report Number: 3007420745-2021-00025
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/30/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/30/2021
• 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