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, sex , and weight not reported.Date of event is unknown.The event is considered to be when the patient began experiencing pain.Product code was not reported and is unknown.The code for plate (hrs) was entered as product code is required to be entered to submit an mdr report.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Implanted date and explanted date were not reported.Concomitant medical products and therapy dates is na to this report.All initial reporter contact information besides phone number (e1) and occupation (e2, e3) 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.No files attached to this report.Investigation: evaluation of similar complaints: similar complaints could not be reviewed as the product line is unknown.Reviewing all removal complaints (without filtering by product line) would not provide further assistance in determining the root cause of the reported event.Device history record (dhr) review: dhr review could not be performed as part / lot number(s) are unknown or could not be narrowed down.As previously mentioned, the product line (and consequently, the part numbers) involved remain unknown.Thus, lot numbers could not be identified, and dhr review was not conducted.Review of surgical technique: instructions for use (ifu) were not identified as the product line involved is unknown.Limited information was provided for the surgical technique / conformance to the ifu, so it is unknown if the physician / user was described to have 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.Due to the nature of the complaint (potential removal case with limited information), simulated use testing was not performed.Investigation conclusion: trilliant surgical was made aware of a potential removal case occurring with doctor 1.However, no product information was available.The applicable sales support specialist followed up with the reporter three (3) times via phone.There is no e-mail address available for the reporter.Thus, written attempt for information could not be made.Due to the limited information, the root cause remains unknown.

Event Description

On 04/26/2021, an individual from facility 1 contacted trilliant surgical's order fullfllment and inventory manager to support a potential need for an upcoming removal surgery with doctor 1 due to a former patient reporting of pain at the surgical site.The order fullfllment and inventory manager followed up with a trilliant surgical sales support specialist to obtain further details surrounding the removal and what type of removal kit will be required.After three (3) follow up attempts via phone, the initial reporter did not reach back out to the sales support specialist and all removal details remain unknown at this point in time.

• 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: 11872305
• MDR Text Key: 260989209
• Report Number: 3007420745-2021-00013
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• 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: 04/26/2021
• 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