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

Model Number 300-70-001

Device Problems Inadequacy of Device Shape and/or Size (1583); Migration (4003)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Non-union Bone Fracture (2369); Skin Inflammation/ Irritation (4545)

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 1-9 below) as part of internal complaint handling activities.Patient weight not reported.Date of event is unknown.The event is considered to be when the patient began experiencing localized pain and irritation at the surgical site.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Initial reporter fax not provided.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.9.No files are attached to this report.Investigation: evaluation of similar complaints: the complaints log was reviewed to identify any similar events involving mib removal due to screw backing out between april 2020 and april 2021.Five (5) similar complaints were identified.Of these five (5) identified complaints, the root causes were as follows: unknown (4) and patient noncompliance (1).None of these related events contained parts from the same lot number as the reported event.Additionally, the complaints log was reviewed to identify any similar events involving hammertoe reoccurring between april 2020 and april 2021.No similar complaints were identified.Device history record (dhr) review : the dhr for lot tsl006966 was reviewed to identify if any significant events occurred corresponding to the hardware involved in the event.Within lot tsl006966, no significant events [reworks (rwks), nonconformances (ncrs), or deviations (dev)] occurred.Dhrs were also reviewed for the following lot numbers associated with the products reported in section d10, concomitant medical products and therapy dates: 2.4mm x 16mm gl locking screw (302-24-016) - lot tsl007191 [manufactured 02/15/2019, udi (b)(4)] which had no associated ncrs, rwks, or deviations.2.4mm x 18mm gl locking screw (302-24-018) - lot tsl007528 [manufactured 06/26/2019, udi (b)(4) ] which had no associated rwks or deviations.Lot tsl007528 had one (1) associated ncr; ncr 19-330 was initiated for one part failing for feature 11 (hexalobe minor diameter).As the parts underwent 100% final inspection and all nonconforming parts were scrapped, ncr 19-330 does not pertain to the reported event.3.4 x 3.0 x 8mm hammertoe implant (204-30-008) - lot tsl005969 [manufactured 05/04/2018, udi (b)(4) ] which had no associated rwks.Lot tsl005969 had two (2) associated ncrs: (1) ncr 18-184 was initiated for utilization of the wrong program during a roving audit.As the roving audit was in addition to the normal inspection practices (wherein the correct program was utilized), product was not impacted.Thus, ncr 18-147 does not pertain to the reported event.(2) ncr 18-147 was initiated due to a set-up sheet error.The failure to revise the set-up sheet prior to production of parts did not adversely affect product as all parts underwent an in-process inspection at an aql 1.0 sampling level as well as a 100% final inspection.Thus, ncr 18-147 does not pertain to the reported event.Lot tsl005969 had one (1) associated deviation; dev 18-0006 was initiated to inspect the major thread diameter utilizing micrometers instead of the vision system.As the major thread diameter was found to be within specification based on the final inspection results, dev 18-0006 does not pertain to the reported event.2.4mm x 28mm tiger cannulated screw (200-24-028) - lot tsl003175 [manufactured 04/19/2016, udi (b)(4) ] which had no associated ncrs, rwks, or deviations.Review of surgical technique: minimally invasive bunion plating system instructions for use, 900-01-016 rev d, and two step hammer toe instructions for use, 900-01-008 revision o, correspond to the event.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 limited information provided and the nature of the event (removal / revision with patient noncompliance), simulated use testing would not provide further evaluation into the root cause of the reported event.Thus, simulated use testing was not performed.Investigation conclusion: (1) mib screw backing out as observed on the x-ray, the tiger screw and gridlock screw are backing out of the mib hardware.This is the first complaint within the identified time period (april 2020 - april 2021) reporting that a gridlock screw backed out of the mib hardware (as all similar complaints identified were pertaining to only a tiger screw backing out of the mib hardware).The sales representative communicated that the patient was noncompliant as she was known to be on her feet often and walked soon after surgery.Thus, the root cause of the screws backing out is patient noncompliance.Per minimally invasive bunion plating system instructions for use, ifu 900-01-016 revision d, the mib construct is intended for temporary fixation until osteogenesis occurs.From reviewing the x-ray, it appears that union occurred.Hammertoe reoccurring: there are no similar complaints for the hammertoe reoccurrence failure mode.The sales representative communicated that the patient was noncompliant as she was known to be on her feet often and walked soon after surgery.Thus, the root cause of the hammertoe reoccurring is patient noncompliance.

Event Description

On 04/07/2021, a trilliant surgical independent sales representative called a trilliant surgical sales support specialist reporting of a minimally invasive bunion (mib) construct and hammer toe implant removal at hospital 1 with doctor 1, that occurred on (b)(6) 2021 on a female patient.The original implantation occurred on (b)(6) 2019 , also at hospital 1 with doctor 1.The patient came in post-operatively reporting of localized pain and irritation at the surgical site.The 2nd metatarsal also was observed to have a recurrent hammertoe.Upon review of initial x-ray, the sales representative stated that the mib construct "seemed broad" and that the 200-24-028 (2.4mm x 28mm tiger cannulated screw) seemed to be backing out as well as the gridlock locking screw (length unknown at this point in the investigation).The sales representative also stated that fusion had not occurred in the 2nd metatarsal.Doctor 1 opted to remove the entire mib construct and the 204-30-008 (3.4 x 3.0 x 8mm hammertoe implant) at the scheduled removal on (b)(6) 2021.To correct the bunion, a 500-10-101 (10mm x 10mm x 10mm staple) was implanted.To correct the hammertoe deformity in the 2nd metatarsal, a longer implant was inserted (204-30-018, 3.4 x 3.0 x 18mm hammertoe implant) and a k-wire was left in for fixation.The sales representative attempted to obtain all associated parts, however the facility retained the parts for their own review.

• Brand Name: MINIMALLY INVASIVE BUNION PLATE, RIGHT
• 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: 11776427
• MDR Text Key: 260986634
• Report Number: 3007420745-2021-00009
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00812926027708
• UDI-Public: (01)00812926027708(10)TSL006966
• 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: 04/30/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 300-70-001
• Device Lot Number: TSL006966
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• 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
• Patient Age: 58 YR