MAUDE Adverse Event Report: TRILLIANT SURGICAL ARSENAL PETITE LAPIDUS PLATE, R; ARSENAL PLATING SYSTEM PLATE

Model Number 300-83-002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Date 01/27/2020

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 1-8 below) as part of internal complaint handling activities.Patient date of birth 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.Concomitant medical products and therapy dates not reported.Followed up? n/a to this report.List correction/removal reporting number: n/a to this report.Associated implanted (and removed) arsenal screw information: brand name: 2.7mm x 16mm arsenal locking screw; common device name: arsenal plating system screw, product code: hwc (screw, fixation, bone).Model #: 308-27-016, lot #: tsl008562, unique identifier (udi) #: (b)(4), pma/510(k): k191009, device manufacture date: 10/03/2019.Brand name: 3.5mm x 20mm arsenal locking screw; common device name: arsenal plating system screw, product code: hwc (screw, fixation, bone).Model #: 308-35-020, lot #: tsl008261, unique identifier (udi) #: (b)(4), pma/510(k): k191009, device manufacture date: 09/28/2019.Brand name: 2.7mm x 12mm arsenal screw; common device name: arsenal plating system screw, product code: hwc (screw, fixation, bone).Model #: 307-27-012, lot #: tsl008217, unique identifier (udi) #: (b)(4), pma/510(k): k191009, device manufacture date: 09/27/2019.Brand name: 2.7mm x 14mm arsenal locking screw; common device name: arsenal plating system screw, product code: hwc (screw, fixation, bone).Model #: 308-27-014, lot #: tsl008072, unique identifier (udi) #: (b)(4), pma/510(k): k191009, device manufacture date: 09/29/2019.Investigation (including evaluation summary of device(s) returned to manufacturer indicated in section) review of surgical technique: the trilliant surgical product manager spoke with the sales representative to gather more information regarding the case.It was provided that the scab on the right great toe of the patient was located directly above the surgical site, above the joint where the plate was placed.It was also documented that the surgeon confirmed the patient was non-compliant to post-operative instructions.The product manager inquired if any testing was performed on the wound site to determine the kind of reaction that had occurred.The reporter did not have any information from the hospital on additional testing completed to analyze the wound.There is limited information provided regarding the implantation technique applied.However, the provided x-rays show that the hardware was appropriately implanted.The dhrs were reviewed for all lot numbers in the reported event.(b)(4) was initiated for one (1) part from lot tsl008217 failing to have the hexalobe drive feature.The arsenal screw utilized within this event was returned and is confirmed to have a hexalobe drive feature.Thus, (b)(4) does not correlate to the reported event.As a result of this dhr review, there is no identified correlation to the event.The returned parts were visually inspected.There are minor scratches on the arsenal petite lapidus plate, r.The minor scratches are of no concern and are likely due to the normal wear and tear that occurs with the insertion and removal process.There are no noteworthy observations in regards to the returned arsenal screws.The returned parts did not undergo dimensional inspection as the reported event did not describe any issues with the performance or mating of the parts.The returned parts did not undergo simulated use testing due to an inability to recreate the excessive abnormal functional stresses applied from patient noncompliance.The complaints log was reviewed for any events reporting irritation/wounds as a result of implanting arsenal hardware.The review was filtered to events between (b)(6) 2019, which is the month the arsenal product line launched, and (b)(6) 2020.No complaints were identified.The root cause of the removal case is patient noncompliance resulting in a wound.It is likely that the excessive abnormal functional stresses applied from patient noncompliance irritated the surgical site scab, resulting in a wound.

Event Description

On (b)(6) 2020, a trilliant surgical sales representative called in to report the removal of a arsenal petite lapidus plate, r (300-83-002) and its associated implanted arsenal screws (reference diameters and lengths below).The date of implantation was (b)(6) 2019, performed by doctor 1 at facility (b)(6) on an (b)(6) year old, (b)(6) pound, female patient.The sales representative reported that doctor 1 saw the patient in-office on (b)(6) 2020.At that time, doctor 1 noticed a scab on the patient's right greater toe developed into a wound.Surgical intervention was scheduled for (b)(6) 2020 at facility x to remove the lapidus plating construct, which is the date the sales representative was notified of the removal.Upon ct evaluation, doctor 1 determined union of the great toe had almost completely formed.In order to ensure 100% union, doctor 1 left the interfragmentary 4.5mm x 45mm headless, stthcs (202-45-045) implanted and only removed the implanted 300-83-002 and associated implanted arsenal screws.The 300-83-002 plate and associated arsenal screws were returned by the sales representative to trilliant surgical's corporate office for further review.All discussed parts were invoiced accordingly to facility (b)(6).On 03/23/2020 additional information: upon return, it was determined that the following screws were associated with this report and invoiced on trilliant surgical invoice number 184919: (2) 308-27-016 (2.7mm x 16mm arsenal locking screw; lot tsl008562); (1) 308-35-020 (3.5mm x 20mm arsenal locking screw; lot tsl008261); (1) 308-27-014 (2.7mm x 14mm arsenal locking screw; lot tsl008072); (1) 307-27-012 (2.7mm x 12mm arsenal screw; lot tsl008217).On 3/25/2020 additional information from the sales representative: the scab on the right great toe of the patient was located directly above the surgical site, above the joint where the plate was placed.The surgeon said that the patient was non-compliant.The reporter did not have any information from the hospital on additional testing completed to analyze the wound.

• Brand Name: ARSENAL PETITE LAPIDUS PLATE, R
• Type of Device: ARSENAL PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston, tx
• Manufacturer (Section G): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston, tx
• Manufacturer Contact: sofia middleton ; 727 north shepherd drive; suite 100; houston, tx ; 3886063
• MDR Report Key: 9921888
• MDR Text Key: 197970538
• Report Number: 3007420745-2020-00020
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00810028390157
• UDI-Public: (01)00810028390157(10)TSL008389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 300-83-002
• Device Lot Number: TSL008389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2019
• 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: 80 YR
• Patient Weight: 64