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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Irritation (1941)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Event description: an event was reported where 4 mib plates were removed due to "hardware irritation".This event was initially collected through trilliant's annual customer feedback survey and specific case details have not been received at this time for any event.This ccr is being closed and four (4) mdr's are being submitted on or before 01/08/2020 in accordance with timeliness and applicable reporting requirements in current versions of sop (b)(4), fda medical device reporting, and sop (b)(4), customer complaint reports.This is report 4 of 4.The below sections will be considered, and if more information becomes available this investigation will be supplemented.Review of surgical technique: a review of the surgical technique cannot be completed at this time.Dhr review: the lot numbers for the mib plates cannot be accurately determined at this time as this surgeon regularly operates at different facilities with different mib system trays and very limited information is available at this time.If and when additional details become available, a dhr review will be completed if lot numbers become known.Visual / dimensional inspection: parts have not been returned at this time and a visual or dimensional inspection cannot be completed.Simulated use testing: due to the nature of the complaint, it is unlikely that simulated use testing can be completed for this event.Evaluation of similar complaints: one other event, ccr 19-04-009, reported that a tiger cannulated screw had backed out of a surgical site from an mib case, but no case details or indication that a removal of hardware occurred was provided.The root cause of ccr 19-04-009 was unknown and was reported to trilliant on 04/18/2019.No additional complaints have been received from this surgeon at this time.Summary / root cause analysis: the root cause of these four (4) reported mib hardware removals remains unknown at this time.

Event Description

Senior marketing manager (b)(4) received feedback from dr.(b)(6) on 12/09/2019 at the closure of trilliant's 2019 products and services survey.When prompted to provide more details if "poor" or "fair" was selected for any of trilliant's product offerings dr.(b)(6), on (b)(6) 2019 wrote the following comment regarding trilliant's minimally invasive bunion system: "had to remove 4 out 5 mib plates that i placed.Unacceptable rate of hardware irritation." to gain further clarification trilliant sales representative (b)(4) was reached out to by sales support.(b)(4) originally had a previous complaint from dr.(b)(6) in regards trilliant's minimally invasive bunion plating system from a conversation at midwest podiatry conference (reference ccr 19-04-009.) however, the nature of the survey feedback and the complaint seem independent.(b)(4), trilliant sales support representative, followed up with dr.(b)(6) and requested information for all 4 of the removals.As of 01/07/2020, information has not been received for any of the four reported removals.This mdr represents report 4 of 4 associated with ccr 20-01-003.Further follow up will occur about ancillary details about original implantation date and explantation date for each of the four patients with (b)(4) and dr.(b)(6).This mdr is being submitted on 01/07/2020 to document the awareness of an event within applicable regulatory timeframes.Follow up mdr's will be submitted within applicable timelines if and when additional information becomes available.

• Brand Name: MINIMALLY INVASIVE BUNION PLATING SYSTEM
• Type of Device: MINIMALLY INVASIVE BUNION (MIB) PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n shepherd dr; ste 100; houston TX 77007
• Manufacturer (Section G): TRILLIANT SURGICAL; 727 n shepherd dr; ste 100; houston TX 77007
• Manufacturer Contact: kaylee ludden ; 727 n shepherd dr; ste 100; houston, TX 77007 ; 8004952919
• MDR Report Key: 9563831
• MDR Text Key: 220978895
• Report Number: 3007420745-2020-00005
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K172178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/09/2019
• Date Manufacturer Received: 12/09/2019
• 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): Hospitalization; Required Intervention