MAUDE Adverse Event Report: TRILLIANT SURGICAL 3.0 X 28MM TIGER CANN. HEADLESS SCREW; TIGER HEADLESS CANNULATED SCREW SYSTEM SCREW

Model Number	202-30-028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
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 as part of internal complaint handling activities.Patient weight not reported.Date of event is unknown.The event is considered to be when the doctor identified the foot deformity present in the patient.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Concomitant medical products and therapy dates is n/a to this report.Initial reporter fax not provided.Device bla number is n/a to this report.Na was not entered within the field for bla number as this caused technicals errors to occur in previous mdr submissions.No files are attached to this report.Investigation evaluation of similar complaints the complaints log was reviewed to identify any similar events involving tiger headless removals between (b)(6) 2020 and (b)(6) 2021.One (1) similar complaint was identified with a root cause of patient noncompliance.This event did not contain parts of the same lot number as the reported event.Device history record (dhr) review lot tsl001943 had no associated nonconformance reports (ncrs), reworks (rwks), or deviations (dev).In conclusion, there were no identified issues related to the complaint event.Review of surgical technique tiger headless cannulated screw system instructions for use, ifu 900-01-004 rev p corresponds to the event.It is documented that the doctor/ user followed the ifu and there are no abnormalities to document.Visual and dimensional inspection, simulated use testing the removed screw was not dimensionally or visually inspected due to the part not being returned.Additionally, simulated use testing was not performed due to the lack of returned parts.Finally, the amount of osteogenesis which had occurred on and around the implanted screw was not able to be simulated.Investigation conclusion within the reported event, the screw was able to complete its intended use of bone fusion.Additionally, trilliant hardware was utilized in combination with competitor hardware.Thus, the reported deformity of the patient cannot be definitively attributed to trilliant hardware, competitor hardware, surgeon technique of the initial procedure, or another unknown variable.Upon additional investigation, the sales representative was asked if she had any further information about the type of deformity present; however, she had no additional information to provide.Thus, the root cause of the removal (i.E., the deformity observed by doctor 1) is unknown.No additional actions are necessary due to the low risk and root cause being attributed to unknown.
Event or Problem Description
On (b)(6) 2021, a trilliant independent sales representative requested a 212-40-003 (3.0/4.0mm headless driver bit) to replace her current driver that broke during a previous removal surgery with doctor 1 at facility x.The sales representative stated that during a removal case on (b)(6) 2021, doctor 1 was removing a competitor's plate / accessory implants and a trilliant headless cannulated screw (202-30-028, 3.0mm x 28mm tiger headless cannulated screw) inserted as the interfragmentary screw.The original implantation occurred on (b)(6) 2019 with previous trilliant representation.The patient, at the time of implantation, was (b)(6) years old (female, dob: (b)(6), weight remains unknown).The patient did not come in experiencing pain, but doctor 1 noticed a foot deformity present in the patient and opted to remove the original plating.Upon removal, doctor 1 had difficulty removing the 202-30-028 out of the surgical site due to bone growth over the tip of the screw.Doctor 1 provided clearance to insert the 212-40-003 into the screw to begin backing it out.After a few turns, the tip of the 212-40-003 broke off into the surgical site.Doctor 1 flushed the site, however he did not have an extra 212-40-003 to complete the removal.Doctor 1 opted to use a competitor's removal set and was successful with the removal.The 212-40-003 shall be returned to corporate for further review.The 202-30-028 has been discarded by the surgical team upon completion.

• Brand Name: 3.0 X 28MM TIGER CANN. HEADLESS SCREW
• Common Device Name: TIGER HEADLESS CANNULATED SCREW SYSTEM SCREW
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston TX 77007 1320
• MDR Report Key: 11362449
• Report Number: 3007420745-2021-00005
• Device Sequence Number: 19442951
• Product Code: HWC
• UDI-Device Identifier: 00812926021775
• UDI-Public: (01)00812926021775(10)TSL001943
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 02/22/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 202-30-028
• Device Lot Number: TSL001943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/22/2021
• 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: 69 YR