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

Model Number 300-70-001

Device Problem Migration (4003)

Patient Problem Irritation (1941)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Investigation summary: an event was reported where an mib plate and hardware needed to be removed as the hardware was causing "irritation" and two tiger cannulated screws were reported as backing out.The sales representative additionally stated that the plate was placed at an "acute" angle, which may have contributed/caused the irritation.Product was not returned for evaluation, but review of the x-ray confirmed the surgery was performed don the patients' right foot, indicating the mib part number 300-70-001, mib plate, right.Two tiger cannulated screws and two 2.4mm gridlock were confirmed by x-ray review to have been implanted, however, lengths of all screws were not able to be determined.Further, the hardware was retained by the patient and a limited investigation was completed using the information provided.Dhr review/ visual inspection/ dimensional inspection/ simulated use testing the above cannot be completed as lot numbers are unknown and the hardware was retained by the patient.Review of case details and x-rays the only information provided from the initial implantation is that the "third screw ran long".X-rays were received and at least 1 tiger cannulated screw (the "interfrag" screw) was able to be visually observed to be backing out.The top of the other distal tiger cannulated screw is visible only slightly above the plate, and is still within the mating portion of the plate.The distal screw that was reported as "running long" was able to be visually confirmed through x-ray review, the tiger cannulated screw where the head is distal (i.E., not the interfrag screw) was observed to pass well through the cortex, which may have not allowed it to gain proper purchase and may have contributed to the slight shift observed.The sales representative also stated that the hardware was placed at an "acute" angle.The placement of the plate was reviewed with engineering manager, cr, and, outside of the confirmed observation that the third screw was "long" (i.E., passed through the cortex), no other conclusions were made about the root cause of the event based on the review of the case details and review of x-rays.The surgeon was satisfied with the results of the correction and the stability of the fusion site.Review of previous complaints 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).Multiple similar complaints were identified through review of capa (b)(4): (b)(4).This was the only report identified during 2018 or 2019 involved with this surgeon or sales representative.In response to several complaints received, capa (b)(4) was initiated on 03/26/19 to determine if any necessary corrective actions were required due to reported mib hardware removals.All listed complaints had an unknown root cause as a result of limited information available or parts not being returned.Reference capa (b)(4) for more information.The ifu was revised as a part of capa (b)(4), effective on 07/01/19.The mib plate associated with this complaint was implanted on (b)(6) 2019 and is considered within the scope of the capa as the other reported events also involved tiger cannulated screws backing out leading to hardware removal.Summary/root cause analysis due to the parts not being returned and lot numbers being unknown, a limited investigation was completed.Through review of the case details and x-rays as well as the previous complaint history and root cause analysis of capa (b)(4), a suspected root cause is that correct screw length may not have been utilized for the tiger cannulated screws, however, this cannot be confirmed as only limited information was available for investigation.The root cause is considered unknown at this time, and the field shall continue to be monitored for need of additional action.

Event Description

On (b)(6) 2019 (b)(6) contacted sales support to request an mib removal kit be sent to (b)(6)hospital to arrive on (b)(6) 2019 for a scheduled removal case on (b)(6) 2019.When (b)(6) was asked why the hardware was being removed he replied that the doctor reported the patient had the 3th and 4th screw backing out so he decided all the hardware was to be removed.(b)(6) was sent the following questions as follow up to report removal and will provide answers once he arrived at the hospital thursday for the case."i'm going to need to report this as a customer feedback assessment! in order to conduct a thorough investigation are you able to provide information for the following questions in regards to the patient? case information for the original mib procedure including facility, date of surgery and patient information (age and gender only): were x-rays were taken intra or post operatively? can you provide these to us for this report if so? for the bunionectomy's what was the bone quality like? did the patient have diabetes? was the patient a smoker? was the patient compliant post op instructions? what was the surgical outcome? as expected? where there any notable challenges during the procedure? case information for the removal cases including facility, date of surgery and patient information (age and gender only) will you be able to send back the removed hardware in a red padded pack?" an x-ray was supplied and (b)(6) will be attending the removal case on (b)(6) 2019 and was asked to return all removed hardware to trilliant's office for further evaluation.On (b)(6) 2019, the following additional information was received: (b)(6) followed up via email to provide more information regarding the hardware removal.Dr.(b)(6) was the performing surgeon in both the original implantation, performed on (b)(6) 2019, and explantation, performed on (b)(6) 2019, both at (b)(6) hospital.The patient was a (b)(6) year-old female.The only comment surrounding the original procedure was the 3rd screw was reported to have gone long but the doctor was okay with it.(b)(6) reported the patient was compliant with the doctors instructions post operatively after the original implantation but it was found two cannulated screws, sizes unknown, were starting to back out and causing irritation so the entire plate was removed on (b)(6) 2019.In (b)(6)'s opinion, the distal portion of the plate was what was causing irritation due to the acute angel of the placement, not the screws.Overall the surgeon was happy with the correction and the fusion site stability.The removed hardware was requested to be kept by the patient and will not be returned to trilliant's corporate office for further review.

Event Description

On 10/28/2019, a trilliant surgical sales representative contacted sales support to request a minimally invasive bunion (mib) plating system removal kit be sent to hospital x to arrive on 10/29/2019 for a scheduled removal case on (b)(6) 2019.When the sales representative was asked why the hardware was being removed, he replied that the doctor reported the patient had the third and fourth screw backing out so he decided all the hardware was to be removed.The sales representative was sent the following questions as follow up to report removal and will provide answers once he arrives at the hospital thursday for the case."i'm going to need to report this as a customer feedback assessment! in order to conduct a thorough investigation are you able to provide information for the following questions in regards to the patient? case information for the original mib procedure including facility, date of surgery and patient information (age and gender only): were x-rays were taken intra or post operatively? can you provide these to us for this report if so? for the bunionectomy's what was the bone quality like? did the patient have diabetes? was the patient a smoker? was the patient compliant post op instructions? what was the surgical outcome? as expected? where there any notable challenges during the procedure? case information for the removal cases including facility, date of surgery and patient information (age and gender only).Will you be able to send back the removed hardware in a red padded pack?" the sales representative will be attending the removal case on (b)(6) 2019 and was asked to return all removed hardware to trilliant's office for further evaluation.11/01/2019 additional information: the sales representative followed up via email to provide more information regarding the hardware removal.Doctor 1 was the performing surgeon in the original implantation, performed on (b)(6) 2019, and explantation, performed on (b)(6) 2019, both at facility x.The patient was a 74 year-old female.The only comment surrounding the original procedure was the third screw was reported to have gone long, but the doctor was okay with it.The sales representative reported that the patient was compliant with the doctor's instructions post-operatively after the original implantation, but it was found that two (2) cannulated screws, sizes unknown, were starting to back out and cause irritation so the entire plate was removed on (b)(6) 2019.In the sales representative's opinion, the distal portion of the plate was what was causing irritation due to the acute angle of the placement, not the screws.Overall the surgeon was happy with the correction and the fusion site stability.The removed hardware was requested to be kept by the patient and will not be returned to trilliant surgical's corporate office for further review.The original procedure performed by doctor 1 was performed at hospital y on (b)(6) 2019.

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 1-8 below) as part of internal complaint handling activities.1.Patient date of birth (a2) and weight (a4) not reported.2.Date of event (b3) is unknown.The event is considered to be the irritation by the plate or screws.3.Catalog# and serial# (d4) not utilized by trilliant surgical.4.Expiration date (d4) is n/a to non-sterile trilliant surgical products.5.Reprocessor name and address (d9) n/a to this report.6.Concomitant medical products and therapy dates (d11) not reported.7.Section h9 n/a to this report.8.No files attached to this report.Corrected information provided in follow-up submission: b1: adverse event and product problem are selected.B3: date of event is unknown.B5: description of event/problem for initial submission - corrected to not identify any physician or institution by name.D2: common device name corrected (product code was correct in initial submission).D3: fax number added.D4: catalog#, serial#.G1: fax number added.G2: fax number added, email address removed.G3:- health professional and distributor are selected, company representative is deleted.H6: method codes 4112 and 3331 added.H10 - corrected data.Additional information provided in follow-up submission: d4: lot#, unique identifier (udi)#.G1: name, telephone, and email address updated as different personnel is submitting the follow-up submission than submitted the initial submission.H10: additional manufacturer narrative.Additional investigation conducted 03/20/2020: lot numbers were identified for this event.The corresponding device history records (dhrs) were reviewed for any significant events (i.E.Nonconformances (ncrs), reworks (rwks), deviations) that may correlate to the reported event.Lot: tsl006255 (minimally invasive bunion plate, right, 300-70-001) [all information reported within form] - no ncrs, rwks, or deviations.Lot: tsl003342 (2.4mm x 16mm tiger cannulated screw, 200-24-016) [udi: (b)(4), tsl003342, manufactured 06/03/2016, product code hwc] - no ncrs, rwks, or deviations.Lot: tsl002632 (2.4mm x 32mm tiger cannulated screw, 200-24-016) [udi: (b)(4), tsl002632, manufactured 07/13/2015, product code hwc] - no ncrs, rwks, or deviations.No adverse events were identified.As a result of the dhr review, it is concluded that there are no identified issues correlating to the reported event.

• Brand Name: MINIMALLY INVASIVE BUNION PLATE, RIGHT
• Type of Device: MINIMALLY INVASIVE BUNION PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n shepherd dr; ste 100; houston TX 77007
• MDR Report Key: 9373232
• MDR Text Key: 205175134
• Report Number: 3007420745-2019-00047
• 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: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300-70-001
• Device Catalogue Number: 300-70-001
• Device Lot Number: TSL006255
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR