MAUDE Adverse Event Report: TRILLIANT SURGICAL (2) 7.0 X 90MM STTCS, (1) 4.5MM X 40MM STTCS; TIGER LARGE CANNULATED SCREW SYSTEM & 4.5MM TIGER CANNULATED SCREW SYSTEM SCREW

Model Number 205-70-090, 200-45-040

Device Problems Migration or Expulsion of Device (1395); Failure to Osseointegrate (1863)

Patient Problem Pain (1994)

Event Date 07/21/2020

Event Type  Injury  

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 1-11 below) as part of internal complaint handling activities.Patient weight not reported.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Lot # and unique identifier (udi) # could not be confirmed.All possibilities are listed below.Reprocessor name and address n/a to this report.Concomitant medical products and therapy dates not reported.Initial reporter fax and email are unknown.Follow-up n/a to this report.Per item 4 above, device manufacture date could not be confirmed.All possibilities are listed below.Recalls number 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 removal for tiger large screws or tiger 4.5 screws between july 2019 and july 2020.One (1) similar complaint was identified with a root cause of patient noncompliance.This complaint did not involve parts from the same potential lot number(s) as the reported event.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 invoices: part number 205-70-090, lot #tsl002539 [manufactured 06/18/2015, udi# (b)(4) which had no associated nonconformance reports (ncrs), reworks (rwks), or deviations.Part number 205-70-090, lot #tsl004310 [manufactured 11/22/2016, udi# (b)(4) which had no associated ncrs, rwks, or deviations.Part number 200-45-040, lot #tsl008168 [manufactured 08/15/2019, udi# (b)(4) which had no associated ncrs, rwks, or deviations.In conclusions, there is no additional information to document regarding dhr review.There were no identified issues related the complaint event.Review of surgical technique: tiger large cannulated screw system instructions for use, ifu 900-01-010 revision i and 4.5mm tiger cannulated screw system instructions for use, ifu 900-01-018 revision a, correspond 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 & dimensional inspection: the part was not returned so no visual or dimensional inspection was performed.Simulated use testing: since the sales representative was unable to attend the removal case, there is limited information and it is unknown what to attempt to recreate.Simulated use testing would not further assist in the determination of the root cause.Thus, simulated use testing was not be performed.Investigation conclusion: it is documented that the patient was experiencing pain.Thus, the removal case was a result of the patient experiencing pain.However, it is unknown what was the source/cause of the pain.It is unknown if the patient was non-compliant to post-operative instructions following the implantation procedure.As x-rays are not available, it is unknown if the initial screw placement was acceptable.It is documented that doctor 1 was concerned about the positioning of the screws prior to the removal case.With limited information available, the root cause of the pain and non-union remains unknown.

Event Description

On (b)(6) 2020, a trilliant surgical sales representative reported notification, same day, of an upcoming hardware removal case by doctor 1.The removal case is currently scheduled to be performed by doctor 1 at hospital 1 on (b)(6) 2020 to remove two (2) 205-70-090 (7.0mm x 90mm sttcs) and one (1) 200-45-040 (4.5mm x 40mm sttcs).The screws were previously implanted by doctor 2 on (b)(6) 2020 at surgery center 1.The patient is a (b)(6)-year-old male.At this time, bone quality, weight, and any underlying patient conditions are unknown by the reporting representative.It is unknown at this time if patient non-compliance is the root cause of the removal procedure, but patient pain was reported.Doctor 1 communicated to the sales representative that he was not seeing union occur and the positioning of the screws were concerning to him.The sales representative will be providing doctor 1 with the instrumentation needed to remove the implanted screws.Due to the covid-19 pandemic, it is unclear if he will be allowed to attended the removal procedure to obtain the hardware removed to send back to trilliant surgical's corporate office for further evaluation.

• Brand Name: (2) 7.0 X 90MM STTCS, (1) 4.5MM X 40MM STTCS
• Type of Device: TIGER LARGE CANNULATED SCREW SYSTEM & 4.5MM TIGER CANNULATED SCREW SYSTEM SCREW
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston, tx
• Manufacturer (Section G): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston, tx
• Manufacturer Contact: sofia middleton ; 727 north shepherd drive; suite 100; houston, tx ; 3886063
• MDR Report Key: 10398442
• MDR Text Key: 204681116
• Report Number: 3007420745-2020-00031
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 205-70-090, 200-45-040
• Device Lot Number: SEE SECTION H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR