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

Model Number	300-70-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Post Operative Wound Infection (2446)
Date of Event	02/01/2020
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 (items 1-8 below) as part of internal complaint handling activities.Patient weight not reported.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Reprocessor name and address n/a to this report.Initial reporter email and fax not reported.Follow up n/a to this report.Correction number n/a to this report.No files attached to this report.Investigation (including evaluation summary of device(s) returned to manufacturer) evaluation of similar complaints: the complaints log was reviewed to identify any similar events involving mib removals between june 2019 and june 2020.Fifteen (15) similar complaint(s) were identified.Common root causes are as follows: 11 unknown, two (2) patient noncompliance, two (2) investigations in-process.Of these 15 complaints, one (1) involved parts from the same lot number as the reported event.This complaint's root cause is unknown.Device history record (dhr) review: the dhr for lot tsl006447 was reviewed to identify if any significant events occurred corresponding to the hardware involved in the event.Within lot tsl006447, no significant events [reworks (rwks), nonconformances (ncrs), or deviations (dev)] occurred.Review of surgical technique: minimally invasive bunion plating system instructions for use, 900-01-016 rev d, corresponds to the event.It is documented that the physician / user was described to have followed the ifu as for the removal as surgical removal notes were provided to doctor 1 following discussions with another doctor, doctor 2.Tips provided by doctor 2 in addition to the steps outlined in 900-01-016 were followed by doctor 1.The provided information does not indicate a failure to follow the ifu by doctor 1.Limited information was provided for the surgical technique / conformance to the ifu within the original implantation, so it is unknown if the physician / user was described to have followed the ifu.Visual inspection: all of the parts that were part of the original mib plating construct were returned.P/n 200-24-028: the cruciform driver feature appears to be completely stripped out as detailed by the sales representative.This supports the non-conforming dimensions noted in the dimensional inspection below as the vision system program was unable to pick up on the applicable features.This damage is related to the complaint as the doctor stripped the screw out during implant removal and ultimately required "vice grips" to properly grab the screw during removal.The root cause of the drive feature stripping cannot be confirmed, but it is likely that bone growth (as the screw was originally implanted 15 months prior to removal) affected the removal of the screw, resulting in the screw head stripping.There was significant surface damage to the head and upper portion of the screw shaft.These visible marks are a result of the "vice grips" utilized by the doctor to complete the screw removal.No visible damage or other observations present on the distal threads.P/n 301-24-020: slight damage observed to the profile of the hexalobe drive feature.The damage did not result in a deficiency during original implantation or hardware removal and is therefore not considered to be related to the complaint.The threaded aspect of the 2.4 mm non-locking screw shows thread deformation along 50% of the thread length.The threads appear to be truncated indicating the thread crest was removed or stripped from the surface.The root cause of this damage cannot be confirmed; however, the damage likely occurred due to unintended interaction between the plate and screw.P/n 302-24-018: both 2.4 mm locking screws show damage / wear around and within the hexalobe drive feature.The damage / wear is likely a result of the insertion and removal of the screws from the original and explant surgery.These observations align with and support the features identified as non-conforming to the specification in the dimensional inspection below as the hexalobe feature is heavily damaged and inconsistent throughout the entire profile.These observations are a result of the intended interaction between screw and driver bit and are not related to the reported complaint.The locking threads on the screw head of the 2.4 mm locking screws both show signs of use indicative of mating, interaction with the associated locking holes of the mib plate.This observation is considered to be a result of the intended interaction and is not related to the reported complaint.No visible damage or other observations present on the distal threads.P/n 300-70-001: signs of wear/damage along the proximal locking holes of the mib plate indicate interaction with the mating 2.4 mm locking screws.This aligns with the observation regarding the locking threads on the screw head of the 302-24-018s.The anodization appears to be removed along the outer edge of the if screw hole indicating interference between the plate and the mating 2.4 mm non-locking screw.This observation aligns with and is considered to be related to the distal thread observation of the 2.4 mm non-locking screw (301-24-020) noted above.It cannot be confirmed if this damage occurred during implantation or removal.Review of the returned mib plate shows a complete, round if screw hole.There is no indication of damage to the thru hole or outer profile.Identifying information is marked on the returned mib plate; including part number and lot number.Dimensional inspection: the returned parts underwent 100% inspection.Pn 300-70-001 (qty 1) inspected to revision c; pn 300-70-001 failed for feature 14 with a value below specification.This feature is the spade if screw hole slot length.However, review of the dhr and visual inspection of the plate confirms the plate was manufactured to rev.B prior to the incorporation of the slot if screw hole feature which was incorporated at rev.C.Therefore, this is not considered to be a nonconformance.Pn 200-24-028 (qty 1) inspected to revision j; pn 200-24-028 failed for features 7-9.These values were noted to all be associated with the cruciform drive feature of the screw head and were all observed to be damaged (reference visual inspection section above) and therefore unable to be measured.Pn 301-24-020 (qty 1) inspected to revision f; pn 301-24-020 was inspected for all screw features.Additionally, all inspected features were noted to be conforming per the specifications.Pn 302-24-018 (qty 2) inspected to revision e; pn 302-24-018 failed for feature 15 (verify hexalobe) for both returned screws.As noted above, the drive features of both screws showed signs of damage/wear.Simulated use testing: simulated use was not conducted for returned device(s) nor with similar parts because the reported granulomatous abscess cannot be recreated with a saw bone sample at corporate.Additionally, it is documented that union occurred.As the hardware had been implanted for approximately 1.5 years, it is likely that bone grow affected the removal of the screw, resulting in the screw head stripping.Simulated use testing cannot simulate bone growth on a saw bone sample.Thus, simulated use testing will not be conducted.Investigation conclusion additional information provided by the sales representative on 07/09/2020 did not provide additional information into the root cause of the hardware removal other than "the patient experienced and reported pain in (b)(6) 2020" in addition to descriptions of "swelling and infection".At the time of the patient report, doctor 1 did not know the root cause of the infection.Months later, as documented within the meeting minutes of the meeting held on (b)(6) 2020, doctor 1 confirmed that a granulomatous abscess had developed over the patient's surgical site.A review of the fluoroscopic image of the construct prior to removal shows the current position of the hardware and bone regrowth on the lateral side of the metatarsal.The provided x-ray confirmed that there is no palpable hardware (i.E.Backed out screws, etc.) to suggest implant irritation.Bone regrowth is shown on the lateral side of the metatarsal bridging the gap between the lateral edges of the proximal metatarsal shaft and the metatarsal head.The root cause for the formation of the abscess remains unknown.As documented within the meeting minutes on (b)(6) 2020, doctor 1 confirmed that the patient had fully healed since the original implantation and that fusion had occurred as intended; however, removal of the hardware was likely necessary in order to clean out the soft tissue growth, mass, and/or scar tissue as needed as a result of the abscess.
Event or Problem Description
06/23/2020 description of incident / event: a trilliant surgical sales representative reported that doctor 1 texted him inquiring who he needed to speak to in regards to removing an implanted minimally invasive bunion (mib) construct.The construct was originally implanted on (b)(6) 2018 at facility 1 by doctor 1.The patient at the time of implantation was (b)(6), now (b)(6)-year-old female.At this time, it's not yet known as to why the construct is being removed.A conference call is scheduled with doctor 1 for 06/25/2020 at 9:30am cst between a trilliant surgical engineering representative, sales support representative, and product manager representative to assist in doctor 1's request regarding removal and to obtain more information.07/09/2020 additional information: the sales representative reported that doctor 1 successfully removed all mib hardware, originally implanted on (b)(6) 2018, on (b)(6) 2020 as planned.The patient experienced and reported pain in (b)(6) 2020.Doctor 1 performed an incision and drainage (i/d) in-office several weeks before the removal of hardware due to swelling and infection.He does not know the root cause of the infection at this time.The sales representative noted the following occurred during the removal procedure: "doctor 1 ended up removing all hardware on tues and it went very smoothly.The only hiccup he had was the 2.4 cann screw.He used the solid slip fit and got 1/3 of it out before it disengaged and then couldn't re-engage it.He then tried the k-wire trick with the cann slip fit, but it couldn't stick.There's was no locking engagement.Fortunately, they had a pair of sterilized vice grips at the surgery center, so he grabbed the head with that and was able to unscrew it.Everything else came out very smoothly and he (we) were all very relieved!! he said that now he knows it can come out relatively easily, he'll start doing them again." all hardware removed will be returned to trilliant surgical by the sales representative for further evaluation.

• Brand Name: MINIMALLY INVASIVE BUNION PLATE, RIGHT
• Common Device Name: MINIMALLY INVASIVE BUNION PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston, tx
• MDR Report Key: 10304779
• Report Number: 3007420745-2020-00028
• Device Sequence Number: 16310364
• Product Code: HRS
• UDI-Device Identifier: 00812926027708
• UDI-Public: (01)00812926027708(10)TSL006447
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: 300-70-001
• Device Lot Number: TSL006447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/21/2020
• 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: 50 YR