MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE TIGER CANNULATED; 3.0MM X 16MM TIGER CANNULATED SCREW3.0MM X 16MM TIGER CANNULATED SCREW

Model Number	200-30-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
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 1-10 below) as part of internal complaint handling activities.Serial/lot # used in surgery unknown.Still remains in patient date of event is unknown.The event is considered to be when the patient experienced the first pain expiration date unknown as lot # could not be confirmed.All lot possibilities are listed below.Initial reporter only has email for hipaa purposes.Reprocessor name and address n/a to this report.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.Device 510k is unknown no files attached to this report.--investigation the complaints log was reviewed to identify any similar events involving a subtalar removal between february 2022 and february 2023.One similar complaints were identified.-device history record (dhr) review - there were no identified issues related to the complaint event.-review of surgical technique - reference ifu and revision: 900-01-002, tiger cannulated screw system ifu, revision p corresponds to the event.Limited information was provided for the surgical technique / conformance to the ifu.-visual inspection - the parts were not returned.Thus, visual inspection did not occur.-dimensional inspection - the parts were not returned.Thus, dimensional inspection did not occur.-simulated use testing - as the part was not returned and limited information is available, simulated use testing did not occur.Additionally, simulated use testing would not be able to recreate the physiological conditions of being implanted for ~4 years and is not able to recreate patient pain.-investigation conclusion - there was one similar complaint for a tiger cannulated screw removal due to patient pain in the timeframe reviewed.The similar complaint had a root cause of unknown, which did not provide further information towards the evaluation and root cause for this ccr 23-02-008.There are no abnormalities in regards to dhr review.It is unknown if the doctor followed the ifu as limited information was provided regarding the original implantation case.As the part was not returned, visual and dimensional inspection did not occur.Simulated use testing did not occur.Due to enovis f&a not being authorized to ship to spain at this time, the reporter has been provided with alternatives to the tiger cannulated removal kit to complete the removal surgery.Should further information become available following the removal case, additional investigation may occur.Based on the limited information available at this time, the root cause shall remain unknown.
Event or Problem Description
On 02/14/2023 an enovis sr rac received an email from a patient stating he is "waiting to be scheduled for removal surgery and has a lot of paint and hopefully removing the screws the will be gone".

• Brand Name: TIGER CANNULATED
• Common Device Name: 3.0MM X 16MM TIGER CANNULATED SCREW3.0MM X 16MM TIGER CANNULATED SCREW
• 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: justin lovelace ; 727 north shepherd drive; suite 100; houston, TX 77007-1320
• MDR Report Key: 16555195
• Report Number: 3007420745-2023-00001
• Device Sequence Number: 2893216
• Product Code: HWC
• UDI-Device Identifier: 00812926020952
• UDI-Public: 00812926020952
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

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
• Device Model Number: 200-30-016
• Device Catalogue Number: 200-30-016
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 200-24-012, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male