MAUDE Adverse Event Report: TRILLIANT SURGICAL MPX GRIDLOCK PLATE; GRIDLOCK PLATING SYSTEM PLATE

Model Number 300-51-0XX

Device Problems Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

Event description: an event was reported in which an x plate of an unspecified size was removed from a patient along with the associated screws.The original surgery was a talonavicular fusion, which occurred approximately 3 years ago, and the surgical site never fused.The patient was an obese (b)(6)-year-old female, and noncompliance was suspected.Dhr review: due to the lot number of the removed plate and the associated screws being unknown, review of the associated dhrs could not be performed.Dimensional/visual inspection and simulated use testing: due to the explanted hardware being retained by the facility, inspection and simulated use testing could not be performed.Evaluation of similar complaints: frm (b)(4), customer complaint report log, was reviewed for similar reported events of gridlock plates being removed due to prolonged non-union.There were no similar events identified in which a gridlock plate was removed from a site that did not fuse after at least two months.Root cause analysis: the plate and screws associated with this event were retained by the facility and could not be assessed during this investigation.As a result, it cannot be verified if the plate or screws contributed to the reported event.There was little information provided concerning the original surgery, which could have affected the potential for the site to not fuse after 3 years.It was noted in the event description that noncompliance was suspected, but this was not confirmed.Therefore, the root cause of this event could not be determined.

Event Description

On (b)(6) 2019, (b)(6) from (b)(6) contacted sales support for a shipment request of gridlock instrumentation for a removal involving a 300-51-00x mpx gridlock plate and multiple screws.The request was forwarded along to (b)(6) sales representative, (b)(6), who attended the removal case on (b)(6) 2019 to retrieve more information.(b)(6) reported that the original surgery was performed in (b)(6) about 3 years ago.The doctor from the original implantation is unknown but the procedure was a talonavicular fusion and the site never fused.Noncompliance is suspected but the trilliant hardware had not broken.The patient was an obese (b)(6)-year-old female.It is unknown whether or not biologics were used at the time of original implantation.On (b)(6) 2019, dr.(b)(6) removed the 300-51-00x plate and associated screws, and used smith and nephew hardware to repair the site.All hardware removed from the patient has been kept by the facility for testing due to hospital policy that does not allow the release of explants.

Event Description

On (b)(6) 2019, sales support was contacted for a shipment request of gridlock instrumentation for a removal involving an mpx gridlock plate (300-51-00x) and multiple screws.The request was forwarded along to the applicable trilliant surgical sales representative, who attended the removal case on (b)(6) 2019 to retrieve more information.The sales representative reported that the original surgery was performed in a different state about 3 years ago.The doctor from the original implantation is unknown, but the procedure was a talonavicular fusion and the site never fused.Noncompliance is suspected, but the trilliant surgical hardware had not broken.The patient was an obese 66-year-old female.It is unknown whether or not biologics were used at the time of original implantation.On (b)(6) 2019, the surgeon removed the 300-51-00x and associated screws, and used competitor hardware to repair the site.All hardware removed from the patient has been kept by the facility for testing due to hospital policy that does not allow the release of explants.

Manufacturer Narrative

Notes to form 3500a and justification for information not provided (in initial or follow-up submission) 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.1.Patient date of birth (a2) and weight (a4) not reported.2.Date of event (b3) is unknown.3.Catalog # and serial # (d4) not utilized by trilliant surgical.4.Expiration date (d4) not applicable (n/a) to non-sterile trilliant surgical products.5.Lot # and unique identifier (udi) # (d4) could not be confirmed.*see note below.7.Reprocessor name and address (d9) n/a to this report.8.Concomitant medical products and therapy dates (d11) not reported.9.Device manufacture date (h4) could not be confirmed.*see note below.10.Section h9 n/a to this report.11.No files attached to this report.Note: because screw length is unknown, brand name (d1) and model # (d4) feature 'xx' in place of the length measurement.Due to this unknown screw length, lot # and unique identifier (udi) # (d4) and device manufacture date (h4) could not be confirmed and device history record (dhr) review could not be conducted.Corrected information provided in follow-up submission.B3 - date of event is unknown.B5 - description of event/problem for initial submission - corrected to not identify any physician or institution by name.B7 - corrected typo.D2 - common device name (product code is correct in initial submission).D3 - fax number added.D5 - operator of device at time of event corrected to patient/lay user as patient noncompliance is suspected.Section f is n/a to this report.H10 - corrected data.Additional information provided in follow-up submission: g1 - name (and email address) updated as different personnel is submitting the follow-up submission than submitted the initial submission.H10 - additional manufacturer narrative.Additional investigation (03/12/2020): potential lot numbers could not be identified for this event.After further investigation, the gridlock screw lot number possibilities cannot be determined due to limited information regarding the length and diameter of the removed gridlock screws.There are too many different options of screw size available to be able to accurately narrow down the potential part number of the removed gridlock screws.Additionally, the specific mpx gridlock plate is unknown.Therefore, the gridlock plate lot possibilities cannot be determined.With no potential lot numbers, device history record (dhr) review cannot be conducted.

• Brand Name: MPX GRIDLOCK PLATE
• Type of Device: GRIDLOCK PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n shepherd dr; ste 100; houston TX 77007
• MDR Report Key: 9014871
• MDR Text Key: 160442571
• Report Number: 3007420745-2019-00040
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K121452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 300-51-0XX
• Device Catalogue Number: 300-51-00X
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/15/2019
• Device Age: 3 YR
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR