MAUDE Adverse Event Report: TRILLIANT SURGICAL ARSENAL L PLATE, LEFT; ARSENAL PLATING SYSTEM PLATE

Model Number	300-88-001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
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 1-9 below) as part of internal complaint handling activities.Patient date of birth and weight not reported.Date of event is unknown.The event is considered to be when the patient began experiencing pain or when the screw began to back out.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Initial reporter fax not reported.Device bla number is n/a to this report.Na was not entered within the field for bla number as this caused technical errors to occur in previous mdr submissions.Section n/a to this report.Section 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 involving an arsenal removal screw backing out between (b)(6) 2020 and (b)(6) 2021.No similar complaints were identified.Device history record (dhr) review: the dhr for lot tsl008647 was reviewed to identify if any significant events occurred corresponding to the hardware involved in the event.Within lot tsl008647, no nonconformances (ncrs), reworks (rwks), or deviations (devs) occurred.The dhrs for the associated parts that were removed were also reviewed to identify if any significant events occurred corresponding to the hardware involved in the event.2.7mm x 26mm arsenal locking screw (308-27-026) - lot tsl008872 [manufactured 12/18/2019, udi (b)(4)] - no associated rwks, ncrs, or devs.2.7mm x 24mm arsenal screw (307-27-024) - lot tsl008517 [manufactured 10/03/2019, udi (b)(4)] - no associated rwks, ncrs, or devs.2.7mm x 22mm arsenal locking screw (308-27-022) - lot tsl008593 [manufactured 10/28/2019, udi (b)(4)] - no associated rwks, ncrs, or devs.In conclusion, there were no identified issues related to the complaint event.Review of surgical technique arsenal plating system instructions for use, 900-01-019 revision a, corresponds to the event.Limited information was provided for the surgical technique / conformance to the ifu so it is unknown if the doctor/ user followed the ifu.Visual and dimensional inspection: the parts were not returned, so no visual or dimensional inspection could be conducted.Simulated use testing: simulated use testing was not conducted for either returned device(s) nor with similar parts.Due to the nature of the event (screw backing out from patient noncompliance), simulated use testing would not be able to recreate the event.Thus, simulated use testing was not performed.Investigation conclusion: there were no similar complaints reporting an arsenal removal for a screw backing out.There were no abnormalities (e.G., nonconformances, reworks, deviations) regarding dhr review.It is unknown if the doctor followed the ifu during the implantation procedure as limited information is available regarding the surgical technique.The parts were not returned and could not be evaluated through visual / dimensional inspection.Simulated use testing was not performed.It is documented within the event description of customer complaint report (ccr) information and evaluation, frm qlt-005h, that "the patient was non-compliant as she began walking too soon after the implantation".Thus, the root cause of the removal and screw backing out are attributed to patient noncompliance.
Event or Problem Description
On (b)(6) 2021, a trilliant surgical independent sales representative emailed two (2) djo foot & ankle sales support specialists to report a removal of a 300-88-001 (arsenal l plate, left) and associated construct on (b)(6) 2021 by doctor 1 at facility 1 on a (b)(6) female patient due to reported patient pain at the surgical site as a screw "backed out".The construct implantation occurred on (b)(6) 2021 by doctor 1 at facility 1 and included the 300-88-001 (arsenal l plate, left), 308-27-026 (2.7mm x 26mm arsenal locking screw), 307-27-024 (2.7mm x 24mm arsenal screw), and 308-27-022 (2.7mm x 22mm arsenal locking screw).It was reported that the patient was non-compliant as she began walking too soon after the implantation.The entire construct was retained by the facility and will not be returned to corporate for further review.

• Brand Name: ARSENAL L PLATE, LEFT
• 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: 12001873
• Report Number: 3007420745-2021-00020
• Device Sequence Number: 4439838
• Product Code: HRS
• UDI-Device Identifier: 00810028390270
• UDI-Public: (01)00810028390270(10)TSL008647
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 300-88-001
• Device Lot Number: TSL008647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/15/2021
• 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: 62 YR