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

Model Number	300-70-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Additional 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 as part of internal complaint handling activities.Investigation evaluation of similar complaints the complaints log was reviewed to identify any similar events involving an mib surgical site causing pain between (b)(6) 2020 and (b)(6) 2021.Seven (7) similar complaints were identified with the following root causes: unknown (5), patient noncompliance (1), ifu not followed (1).None of these events contain parts of the same lot number as the reported event.Device history record (dhr) review lot tsl009616 had no associated reworks (rwks) or deviations (dev).Nonconformance report (ncr) ncr 20-122 was initiated for one part failing for the large external radius.As the lot underwent 100% final inspection, all nonconforming parts were identified and scrapped.Thus, ncr 20-122 does not correlate to the reported event.In conclusion, there were no identified issues related to the complaint event.Review of surgical technique minimally invasive bunion plating system instructions for use, ifu (b)(4) revision d corresponds to the event.It is unknown if the doctor/ user followed the ifu as there was limited information provided for the surgical technique / conformance to the ifu.Visual and dimensional inspection the part was not returned, so visual and dimensional inspection could not be conducted.Simulated use testing due to the nature of the event ("a small fragment of bone dislodged at the surgical site causing the irritation and redness where the patient was experiencing pain" as documented on customer complaint report (ccr) additional information, frm qlt-005l), simulated use testing would not be able to fully recreate the issue.Thus, simulated use testing was not performed.Investigation conclusion the identified similar complaints did not further assist in evaluating a root cause.There were no abnormalities in regards to dhr review or surgical technique.As the parts were not returned, visual inspection and dimensional inspection could not be performed.In review of the provided x-ray, a fracture was observed.Upon review of the surgical site during the removal case, doctor 1 identified that "fusion had occurred and that there was a small fragment of bone dislodged at the surgical site causing the irritation and redness where the patient was experiencing pain" according to customer complaint report (ccr) additional information, frm qlt-005l.There was no confirmed report of patient noncompliance; however, the x-ray supports the speculation that the foot underwent external trauma (i.E.Fall, trip) that resulted in the observed fracture.Doctor 1 and the sales representative could not confirm the cause of the fracture as documented in customer complaint report activity log, frm qlt-005g.However, it was stated that the fracture is not expected to be in relation to the implantation of the mib construct.Doctor 1 did not remove the mib construct based on reasonable judgement / evaluation concluding that the source of pain was resulting from a small fragment of bone that was dislodged.Thus, the pain is not anticipated to be attributed to the implantation of the mib construct, and the root cause of pain shall be patient anatomy (unrelated to mib construct).
Event or Problem Description
On (b)(6) 2021, a trilliant surgical independent sales representative reported that during a post-operative review, doctor 1 had a patient report of pain at the surgical site of a previously implanted 300-70-002 (minimally invasive bunion plate, left) (original implantation: (b)(6) 2020, patient details are currently unknown).Doctor 1 saw the plate had shifted and wasn't achieving optimal compression.A removal was scheduled for (b)(6) 2021 and further details regarding patient non-compliance and removal details will be obtained from the sales representative upon completion of surgery.All further details obtained shall be documented after the scheduled removal.Additional information obtained 01/22/2021: on 01/22/2021, a trilliant surgical sales support specialist interviewed the sales representative in regards to the removal case on (b)(6) 2021 with doctor 1 at facility 1.Doctor 1 stated that the patient was experiencing localized pain at the surgical site and intended on removing the full construct.However, upon review, doctor 1 noticed fusion had occurred and that there was a small fragment of bone dislodged at the surgical site causing the irritation and redness where the patient was experiencing pain.Doctor 1 removed the bone fragment and did not have to remove the mib construct.He also opted to insert dorsally a 202-20-018 (2.0mm x 18mm tiger headless screw) and a 307-22-018 (2.2mm x 18mm arsenal non-locking screw) to achieve optimal fixation.The patient details obtained were as follows: female patient, (b)(6) years old, dob unknown upon second interview, patient weight will remain unknown and all good faith effort has been achieved.

• Brand Name: MINIMALLY INVASIVE BUNION PLATE, LEFT
• Common Device Name: MINIMALLY INVASIVE BUNION PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston TX 77007 1320
• MDR Report Key: 11349061
• Report Number: 3007420745-2021-00004
• Device Sequence Number: 2564980
• Product Code: HRS
• UDI-Device Identifier: 00812926027715
• UDI-Public: (01)00812926027715(10)TSL009616
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K172178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 300-70-002
• Device Lot Number: TSL009616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR