MAUDE Adverse Event Report: TRILLIANT SURGICAL 8 HOLE CONTOURED VL GRIDLOCK FIBULA PLATE; GRIDLOCK ANKLE PLATING SYSTEM PLATE

Model Number 300-61-005

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

An event was reported to trilliant surgical on (b)(6) 2019 involving screws backing out of a surgical site a week after implantation of a 300-61-005 8 hole contoured vl gridlock fibula plate.X-rays were provided and review of the x-rays confirmed the reported event, the screws could be seen backing out.The complainant provided that the patient was not experiencing pain, however, had a traumatic event the day after surgery (fell down stairs).The surgeon scheduled a revision surgery and hardware was removed on (b)(6) 2019 and was re-plated with a competitor's product.Product was not returned to trilliant surgical.Very limited information is available for investigation.The lot number of the screws and plate are unknown and a dhr review cannot be completed.As parts were not returned, a visual or dimensional inspection cannot be performed.The complaint log was reviewed, this is the only complaint received for this part number.The root cause of the event is likely due to the traumatic even described in the event description; the patient fell down the stairs the day after surgery, likely causing the recently implanted hardware to become unstable and leading to the screws backing out.

Event Description

Dr.(b)(6) repaired an ankle fracture on (b)(6) 2019 with a 300-61-005 8 hole contoured vl gridlock fibula plate filled with 5 locking and 3 non-locking screws.The patient came in for her regular post-op appointment one week after surgery ((b)(6) 21019) with no report of pain.X-rays revealed that the most distal screws (a combination of both locking and non-locking) had backed out of the site and were no longer biting the plate or the bone.After discussion with the patient, dr.(b)(6) learned that the patient fell down the stairs on (b)(6) 2019, the day after surgery.Dr.(b)(6) scheduled a revision surgery on (b)(6) 2019 where he removed all trilliant hardware from the patient.He decided to utilize a competitor's hardware to re-plate the site.The 300-61-005 8 hole contoured vl gridlock fibula plate and all associated screws (as well as the large tiger screws for the medial malleolus repair) were intended to be returned to corporate for review.Trilliant was informed on (b)(6) 2019 that parts were lost in transit and not returned to corporate.

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 1-10 below) as part of internal complaint handling activities.1.Patient age, date of birth (a2), and weight (a4) not reported.2.Date of event (b3) unknown.The event is considered to be the screws backing out of the site due to the patient falling down the stairs.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.All possibilities are listed below.6.Reprocessor name and address (d9) n/a to this report.7.Concomitant medical products and therapy dates (d11) not reported.8.As a result of item 5 above, device manufacture date (h4) could not be confirmed.All possibilities are listed below.9.Section h9 n/a to this report.10.No files attached to this report.Corrected information provided in follow-up submission: b1 - product problem should be selected in addition to adverse event.B3 - date of event left blank because unknown.B5 - description of event/problem for initial submission - corrected to not identify any physician or institution by name.D5 - operator of device was selected as patient/lay user as the event is a result of patient noncompliance.The operator of the device when the event occurred (force causing the screws to back out) was the patient.E1 - initial reporter corrected to physician who reported the event to the distrubutor (sales representative).Sales representative's email address is removed.Section f is n/a to this report.G3 - report source corrected to health professional and distributor and selection for company representative removed.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.Investigation summary (omitted with original submission): device history record (dhr) review: while the specific lot number of the involved plate (8 hole contoured vl gridlock fibula plate, 300-61-005) could not be identified, the following lot numbers were identified and reviewed as possibilities: 1.Lot #tsl005880 [manufactured 02/08/2018, udi (b)(4) which had no associated reworks (rwks).Lot #tsl005880 had one (1) associated nonconformance report (ncr); (b)(4) was initiated for 13 parts failing for feature 22 (contoured height).The rejected samples were under specification.It was determined that the nonconformance was likely due to excessive polishing.Document change notice (dcn) 2374 was used to update the inspection method for feature 22.The parts underwent reinspection for the inspection method described in dcn 2374 and passed.Thus, the parts were dispositioned as "use as is".The change of inspection method was to allow for a more consistent and accurate measurement of the contoured height without the influence of the thickness of plate.As the parts were found to be acceptable per the inspection method documented in dcn 2374, (b)(4) does not correlate to the reported event.Additionally, the contour height would not impact the screws backing out.Lot #tsl005880 had one (1) associated deviation; dev 18-0001 was initiated to utilize equipment id 9004 for the alkaline rinse tank rather than equipment 9025.Equipment 9025 was removed from service for repair.Substituting equipment for the alkaline rinse tank does not correspond to the reported event.2.Lot #tsl006175 [manufactured 06/20/2018, udi (b)(4) which had no associated ncrs, rwks, or deviations.As a result of the dhr review, it is concluded that none of the identified significant events correspond to the reported event.

Event Description

Doctor 1 repaired an ankle fracture on march 4, 2019 with an 8 hole contoured vl gridlock fibula plate (300-61-005) filled with five (5) locking and three (3) non-locking screws.The patient came in for her regular post-op appointment one week after surgery ((b)(6)2019) with no report of pain.X-rays revealed that the most distal screws (a combination of both locking and non-locking) had backed out of the site and were no longer biting the plate or the bone.After discussion with the patient, doctor 1 learned that the patient fell down the stairs on (b)(6) 2019, the day after surgery.Doctor 1 scheduled a revision surgery on march 13, 2019 where he removed all trilliant hardware from the patient.He decided to utilize a competitor's hardware to re-plate the site.

• Brand Name: 8 HOLE CONTOURED VL GRIDLOCK FIBULA PLATE
• Type of Device: GRIDLOCK ANKLE PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n sheperd dr; ste. 100; houston TX 77007
• MDR Report Key: 8560814
• MDR Text Key: 145921219
• Report Number: 3007420745-2019-00016
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K160177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 300-61-005
• Device Catalogue Number: 300-61-005
• Device Lot Number: SEE SECTION H10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention