MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE 7 HOLE VL GRIDLOCK FIBULA PLATE; GRIDLOCK ANKLE PLATING SYSTEM PLATE

Model Number	300-60-001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 12/23/2021, djo f&a independent sales representative emailed djo f&a sales support specialist to report of a removal case including a 304-35-020 (3.5mm x 20mm gridlock ankle screw), (2) 305-35-016 (3.5mm x 16mm gridlock ankle locking screw), 305-35-014 (3.5mm x 14mm gridlock ankle locking screw), 304-35-014 (3.5mm x 14mm gridlock ankle screw), (2) 304-35-012 (3.5mm x 12mm gridlock ankle screw) and 300-60-001 (7 hole vl gridlock fibula plate) due to the patient reporting "plate irritation" at facility 1 by doctor 1 on a (b)(6) year old female patient.The implantation occurred on (b)(6) 2021 by doctor 1 at facility 1.X-rays were obtained of the original implantation and after the removal.Djo f&a independent sales representative stated that "everything healed" from the original implantation and the removal was due to "plate irritation".Djo f&a independent sales representative was not able to collect the removed parts, 304-35-020, 305-35-016, (2) 305-35-014, 304-35-014, (2) 304-35-012, and 300-60-001, as the facility retains them for their own quality assessment and therefore, will not be returned to corporate for further review.
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.Date of event is unknown.The event is considered to be when the patient began to experience discomfort.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Device bla number is n/a to this report.The devices were not returned for evaluation.Investigation: evaluation of similar complaints: the complaints log was reviewed to identify any similar events involving a gla removal between december 2020 and december 2021.One similar complaint was identified.The root cause was no identified defect.The similar complaint did not have confirmed parts from the same lot number as the reported event (as the lot numbers for the reported event are potentials).Device history record (dhr) review: lot #tsl010521 [manufactured 12/16/2020, udi (b)(4)] had no associated ncrs, rwks, or deviations.Lot #tsl010807 [manufactured 02/23/2021, udi (b)(4)] had no associated ncrs, rwks, or deviations.Lot #tsl010802 [manufactured 03/01/2021, udi (b)(4)] had no associated ncrs, rwks, or deviations.Lot #tsl010520 [manufactured 12/18/2020, udi (b)(4)] had no associated ncrs, rwks, or deviations.Lot #tsl010516 [manufactured 12/09/2020, udi (b)(4)] had no associated ncrs, rwks, or deviations.Lot #tsl005282 [manufactured 01/25/2018, udi (b)(4)] had no associated rwks or deviations.(b)(4) was initiated for operation 200 missing print out inspection data from the (b)(4).As the lot underwent 100% final inspection with conforming results, the lot was not impacted by the quality event.Thus, (b)(4) does not pertain to the reported event.Review of surgical technique: gridlock ankle plating system instructions for use, ifu (b)(4) revision m, corresponds to the event.Limited information was provided for the surgical technique / conformance to the ifu, so it is unknown if the physician / user was described to have followed the ifu.Visual inspection: the parts were not returned and could not be visually evaluated.Dimensional inspection: the parts were not returned and could not be dimensionally evaluated.Simulated use testing: simulated use testing was not conducted for either returned device(s) nor with similar parts.Simulated use testing was not performed as there are limitations in which simulated use testing would not be able to recreate the physiological conditions of being implanted for 9 months as well as "plate irritation".Investigation conclusion: similar complaint (b)(4) was identified.However, the root cause for (b)(4) was attributed to no identified defect (as the doctor confirmed that there was no issue with trilliant surgical gla hardware and the observed infection was attributed to another company's product).Thus, the similar complaint did not provide further assistance into the evaluation of the root cause of this (b)(4).There were no abnormalities in regards to dhr review.It is unknown if the user followed the ifu, as limited information is available regarding the implantation procedure.The parts were not returned and could not undergo visual inspection nor dimensional inspection.Simulated use testing was not performed.Though the reporter stated that "everything healed" from the original implantation, the root cause of the experienced "plate irritation" remains unknown.

• Brand Name: 7 HOLE VL GRIDLOCK FIBULA PLATE
• Common Device Name: GRIDLOCK ANKLE PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston TX 77007 1320
• Manufacturer (Section G): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston TX 77007 1320
• Manufacturer Contact: kayla gary ; 727 north shepherd drive; suite 100; houston, TX 77007-1320 ; 8777783864
• MDR Report Key: 13309608
• Report Number: 3007420745-2022-00003
• Device Sequence Number: 3424715
• Product Code: HRS
• UDI-Device Identifier: 00812926025438
• UDI-Public: (01)00812926025438(10)TSL005282
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160177
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2022

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: 300-60-001
• Device Lot Number: TSL005282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (2) 304-35-012, 3.5MM X 12MM GLA SCREW; (2) 305-35-014, 3.5MM X 14MM GLA LOCKING SCREW; 304-35-014, 3.5MM X 14MM GLA SCREW; 304-35-020, 3.5MM X 20MM GLA SCREW; 305-35-016, 3.5MM X 16MM GLA LOCKING SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female