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

Model Number 300-70-00X

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Tingling (2171)

Event Type  Injury  

Manufacturer Narrative

Two patients underwent a bunionectomy and had to have the hardware removed approximately 3 months after the procedure due to a "tingling" sensation.The surgeon reported that one of those patients (patient #2) had a slightly prominent screw that may have been irritating a nerve.The surgeon did not identify anything unusual with the other patient and is unsure of why she described the "tingling" sensation.Review of surgical technique: no surgical technique has been documented from either the minimally invasive white paper or email interactions with the surgeon.At this time, there is no evidence of improper surgical technique.Dhr review: no dhr review could be conducted due to the part numbers and lot numbers being unknown.Visual / dimensional inspection: no visual / dimensional inspection could be conducted due to the hardware being disposed at the time of the removal procedure.Simulated use testing: no simulated use testing could be conducted due to the hardware being disposed at the time of the removal procedure.Evaluation of similar complaints: frm qlt-005c, customer complaint report log, was reviewed for similar events involving the mib plating system within the last year (october 2018 - october 2019).Two complaints were identified to be relevant to this event: ccr 19-02-010 and ccr 19-07-005.Both instances were mib removals and have an unknown root cause.Summary / root cause analysis: due to minimal information available and the hardware being scrapped at the removal procedures, there is not much to conclude other than the root cause is unknown.If the surgeon responds at a further date with more information, investigation will be conducted further.

Event Description

On 10/09/2019, trilliant's senior marketing manager sent correspondence regarding the below excerpt from a proposed product white paper.This event documents 2 patients; this mdr is regarding patient number 2.For patient number 1, a separate mdr shall be filed."two of the patients shared that they were having a "tingling" sensation over the hardware and asked for the plate and screws to be removed.This was just over three months following the initial procedures.The plates and screws were removed and the patients healed uneventfully without any future complications.X-rays were taken following the hardware removal to show the extent of the bone callus formation.".

Event Description

In addition to the information provided in the initial submission for mdr report 3007420745-2019-00045, the surgeon reported that this patient had a slightly prominent screw that he believed was irritating a nerve.

Manufacturer Narrative

Notes to form 3500a and justification for information not provided (in initial or follow-up submission) as required per 21cfr803.52 is below.Trilliant surgical attempted to obtain the omitted information (items 1-11 below) as part of internal complaint handling activities.1.Patient age at time of event, date of birth (a2) and weight (a4) not reported.2.Date of event (b3) is unknown.3.Catalog # and serial # (d4) not utilized by trilliant surgical.4.Expiration date (d4) not applicable (n/a) to non-sterile trilliant surgical products.5.Lot # and unique identifier (udi) # (d4) could not be confirmed.*see note below.6.Implanted date (d6) and explanted date (d7) not reported.7.Reprocessor name and address (d9) n/a to this report.8.Concomitant medical products and therapy dates (d11) not reported.9.Device manufacture date (h4) could not be confirmed.*see note below.10.Section h9 n/a to this report.11.No files attached to this report.Note: because plate orientation is unknown, brand name (d1) and model # (d4) feature 'xx' in place of the orientation identifier.Due to this unknown orientation, lot # and unique identifier (udi) # (d4) and device manufacture date (h4) could not be confirmed and device history record (dhr) review could not be conducted.Additional information provided in follow-up submission b5 sentence was omitted in original submission.G1 name (and email address, telephone) updated as different personnel is submitting the follow-up submission than submitted the initial submission.H10 additional manufacturer narrative.Additional investigation (03/12/2020).The original date of implantation is unknown.The facility is unknown.It also cannot be determined which orientation of the mib plate was utilized.As a result of the limited information available, potential lot numbers could not be identified and device history record (dhr) review cannot be conducted.

• Brand Name: MINIMALLY INVASIVE BUNION PLATE, XX
• Type of Device: MINIMALLY INVASIVE BUNION (MIB) PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n shepherd dr; suite 100; houston TX 77007
• MDR Report Key: 9295223
• MDR Text Key: 165597235
• Report Number: 3007420745-2019-00045
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 300-70-00X
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/09/2019
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention