MAUDE Adverse Event Report: TRILLIANT SURGICAL ARSENAL 5TH MET HOOK PLATE, L; ARSENAL PLATING SYSTEM PLATE

Model Number	300-84-001
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/20/2020
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 1-7 below) as part of internal complaint handling activities.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Initial reporter fax number not reported.Device bla number is n/a to this report.Na was not entered within this field as this caused technical errors to occur in previous mdr submissions.Section h2 n/a to this report.Section h9 n/a to this report.No files attached to this report.Investigation: -evaluation of similar complaints the complaints log was reviewed to identify any similar events related to removals involving an arsenal hook plate between (b)(6) 2019 (launch of the arsenal product line) and (b)(6) 2020.No similar complaints were identified.Device history record (dhr) review: while the specific lot number of the involved implants could not be identified, the following lot numbers were identified and reviewed as possibilities based on the applicable sales representative's current inventory.The dhr for lot tsl008505 was reviewed to identify if any significant events occurred corresponding to the hardware involved in the event.Within lot tsl008505, no significant events reworks (rwks), nonconformances (ncrs), or deviations (dev) occurred.Part number 307-27-014, lot #42874 [manufactured 12/17/2019, udi: (b)(4), which had no associated ncrs, rwks, or deviations.Part number 308-27-010, lot tsl009076 [manufactured 01/02/2020, udi# ((b)(4), which had no associated ncrs, rwks, or deviations.In conclusion, there were no identified issues related to the complaint event.Review of surgical technique: instructions for use arsenal plating system, ifu 900-01-019 revision a, corresponds to the event.It is documented that the doctor/ user followed the ifu and there are no abnormalities to document.Note: from the information available, it is determined that the doctor followed the instructions for use during the implantation procedure.However, the doctor "thought a removal procedure would be needed due to placement of the plate.The plates tines were not fully inserted into the base of the 5th metatarsal, making it so the plate wasn't flush against the base." visual and dimensional inspection, simulated use testing the parts were not returned so no visual, or dimensional inspection could be performed.Simulated use testing would not be able to recreate the pain the patient experienced from the plate not being fully inserted.Thus, simulated use testing is not necessary for the evaluation of the complaint, and was not performed.Investigation conclusion: there are no similar complaints pertaining to an arsenal hook plate removal.The respective dhrs do not show any significant findings (i.E.Nonconformances, reworks, deviations) that correlate to the reported event.During the implantation procedure, the doctor reported that he expected the need for a future removal procedure based on the arsenal 5th met hook plate tines not being fully inserted into the base of the 5th metatarsal.As a result of the plate tines not being fully inserted, the plate was not flush against the base.The provided x-rays confirm that the plate was not fully inserted and was not seated flush against the bone.For comparison purposes, a review of val-015-0004, pr-015, arsenal plating system simulated use report, was conducted.In contrast from the reviewed x-ray, a properly placed 5th met hook plate should be placed so that the tines are fully inserted into the base of the 5th metatarsal and flush against the bone.The provided x-rays confirm that union occurred.As can be concluded based on the commentary provided by the surgeon and the comparison seen in the x-ray and simulated use report referenced above, the root cause of the removal and patient pain can be attributed to user error wherein the surgeon did not properly place / insert the arsenal 5th met hook plate into the base of the 5th metatarsal to ensure reduction.Malfunction of the device did not occur.The device performed as intended, resulting in union occurring.The complaint is a result of the plate not being fully inserted by the surgeon during the implantation procedure.
Event or Problem Description
On 09/08/2020, a trilliant surgical sales representative reported a removal of an implanted 300-84-001 (arsenal 5th met hook plate, l).The reported removal was performed by doctor 1 at facility x on (b)(6) 2020, after the patient reported pain during a postoperative appointment in (b)(6) 2020.It was later confirmed that the first report of pain occurred on (b)(6) 2020.The patient was a (b)(6)-year-old (dob: (b)(6) 1970) female, (b)(6)pounds, with reported good bone quality.The patient did not have any reported comorbidities, and no non-compliance was reported.The 300-84-001 was originally implanted on (b)(6) 2020, at facility x by doctor 1.At the time of implantation, the sales representative reported that doctor 1 thought a removal procedure would be needed due to the placement of the plate.The plates tines were not fully inserted into the base of the 5th metatarsal, making it so the plate wasn't flush against the base.In (b)(6) 2020, the patient reported in a postoperative appointment that she was experiencing pain, unknown if the pain was localized or not.Union of the fracture in the 5th metatarsal was seen upon x-ray examination.A removal procedure was scheduled for (b)(6) 2020, where doctor 1's resident, doctor 2, removed the 300-84-001 and three (3) screws implanted on (b)(6) 2020: one (1) 307-27-014 (2.7mm x 14mm arsenal screw) and two (2) 308-27-010 (2.7mm x 10mm arsenal locking screw).Nothing more was implanted due to union occurring.The 300-84-001, 307-27-014, and two (2) 308-27-010s were disposed of following the removal, and will not be returning to trilliant surgical's corporate office for further evaluation.

• Brand Name: ARSENAL 5TH MET HOOK PLATE, L
• Common Device Name: ARSENAL PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston TX 77007 1320
• MDR Report Key: 10634948
• Report Number: 3007420745-2020-00040
• Device Sequence Number: 2720270
• Product Code: HRS
• UDI-Device Identifier: 00810028390201
• UDI-Public: (01)00810028390201(10)TSL008505
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2020

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: 300-84-001
• Device Lot Number: TSL008505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/06/2020
• 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
• Patient Weight: 88