MAUDE Adverse Event Report: TRILLIANT SURGICAL 2.4MM X 24MM GL SCREW; GRIDLOCK PLATING SYSTEM SCREW

Model Number 301-24-024

Device Problem Migration (4003)

Patient Problem Foreign Body In Patient (2687)

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 as part of internal complaint handling activities.Patient date of birth and weight not reported.Date of event is unknown as it was not reported when it was noticed that the screw was backing out of the surgical site.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.As a result, device manufacture date could not be confirmed.All possibilities are listed below.Investigation: review of surgical technique: limited information was provided regarding the surgical technique utilized when inserting and removing the parts.A trilliant surgical r&d engineer was shown the provided x-rays and interviewed to determine a potential root cause of the previously described event.He described the screws to be in the appropriate locations with the appropriate angles.He noticed that the 2.4mm gridlock non-locking screw utilized in the proximal mib plate hole may have been not long enough to reach appropriate length within the lateral cortex.Additionally, the surgeon utilized a gridlock screw, which has a larger head than the tiger cannulated screw.Thus, gridlock screws need more countersinking prior to screw insertion.It is likely that the surgeon did not countersink enough for the gridlock screw, which later resulted in it backing out.Dhr review: while the specific lot number of the involved implant could not be identified, the following lot numbers were identified and reviewed as possibilities.Lot tsl004815 [manufactured 07/27/2017, udi (b)(4)], which had no associated nonconformance reports (ncrs), reworks (rwks), or deviations.Lot tsl000844 [manufactured 04/24/2014, udi (b)(4)], which had no associated ncrs, rwks, or deviations.Visual / dimensional inspection: the 2.4mm x 24mm gridlock non-locking screw was discarded at the case and not returned to corporate.Thus, visual / dimensional inspection could not be conducted.Simulated use testing: the event involved a gridlock non-locking screw protruding out of the proximal mib plate hole.As the event occurred over a duration of time due to compression forces as well as the potential of not choosing a long enough screw, the event cannot be recreated at corporate.Simulated use testing will not be conducted.Evaluation of similar complaints: the complaints log was reviewed to identify any similar events involving an mib removal between december 2018 and december 2019.Eleven complaints were identified.In reviewing these complaints, none were helpful in determining the root cause of this event as all root causes were unknown.Summary / root cause analysis: from view of the x-ray, it is believed that the doctor did not choose a long enough screw which was addressed in capa (b)(4).There is also potential that the doctor did not countersink enough for the gridlock screw head.There is not a definitive root cause as limited information was provided.Thus, the root cause of the event remains unknown.

Event Description

A surgeon performed a bunionectomy on a (b)(6)-year-old female patient on (b)(6) 2019 utilizing the minimally invasive bunion plating system.According to the trilliant sales representative, a 2.4mm gridlock non-locking screw was backing out of the surgical site and was removed on (b)(6) 2019 in the surgeon's office.This 2.4mm screw was discarded upon removal.The trilliant sales representative cannot recall when she was made aware of this need for removal.

• Brand Name: 2.4MM X 24MM GL SCREW
• Type of Device: GRIDLOCK PLATING SYSTEM SCREW
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston TX 77007 1320
• Manufacturer (Section G): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston TX 77007 1320
• Manufacturer Contact: sofia middleton ; 727 north shepherd drive; suite 100; houston, TX 77007-1320 ; 7133886063
• MDR Report Key: 9650189
• MDR Text Key: 190802078
• Report Number: 3007420745-2020-00009
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 301-24-024
• Device Lot Number: SEE SECTION H10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/30/2020
• 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: 34 YR