MAUDE Adverse Event Report: TRILLIANT SURGICAL PETITE MPJ PLATE, LEFT; GRIDLOCK PLATING SYSTEM PLATE

Model Number	300-52-005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/18/2021
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 (items 1-10 below) as part of internal complaint handling activities.Patient date of birth estimated to be (b)(6) 1959 as only the birth year (1959) is known) patient weight not reported.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Implantation date is estimated as (b)(6) 2018 as implantation was reported to have occurred "roughly 3 years ago (end of 2017/early 2018)".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 technical errors to occur in previous mdr submissions.No files are attached to this report.Investigation (including evaluation summary of device).Evaluation of similar complaints.The complaints log was reviewed to identify any similar events involving a gridlock plate breaking after implantation between (b)(6) 2020 and (b)(6) 2021.Two (2) similar complaints were identified, both with a root cause of unknown.These events did not contain parts of the same lot number as the reported event.Device history record (dhr) review.Lot tsl004803 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.Gridlock plating system instructions for use, ifu 900-01-006 revision n corresponds to the event.It is documented that the doctor/ user followed the ifu and there are no abnormalities to document.Note: while the doctor did follow the steps outlined in the ifu, it is noteworthy that the hardware was implanted for ~3 years.The ifu states, "the gridlock plating system is intended for temporary fixation only until osteogenesis occurs." research has demonstrated that the mean time to union for a locked mpj plate is approximately 66 days with a 92% rate of fusion.Hardware failure may occur during the initial postoperative period due to improper technique or surgeon error.Because the complaint was reported long after the initial postoperative period, the failure mode is not expected to be a result of improper technique or surgeon error.Broken hardware often correlates to motion at the fusion site or patient noncompliance.There is no report of patient noncompliance.There is no report of observed motion at the fusion site.Visual inspection.The complaint related parts were returned and underwent visual inspection.The gridlock locking screws demonstrated wear among the hexalobe and locking threads.The locking threads are suspected to be damaged from locking and unlocking into the plate during the insertion and removal procedures as well as from the breakage of the plate.The hexalobe is also suspected to be worn from interacting with the driver during the insertion and removal procedures.The gridlock non-locking screws demonstrated wear among the hexalobe.The hexalobe is suspected to be worn from interacting with the driver during the insertion and removal procedures.The gridlock plate (pn: 300-52-005, lot #: tsl004803) was confirmed to be broken.There are minor scratches / dents displayed along the plate.In a magnified view of both sides of breakage on the plate, there is observed damage to the threads and land.Dimensional inspection.Devices that were dimensionally inspected were not within specification.·301-30-012 - the 3.0mm x 12mm non-locking screw is failing for feature 10 (hexalobe minor diameter) and feature 13 (verify hexalobe).The hexalobe damage is suspected to be resulting from the wear and tear that occurs during insertion and removal.·301-30-014 - the 3.0mm x 14mm non-locking screw is failing for feature 10 (hexalobe minor diameter) and feature 13 (verify hexalobe).The hexalobe damage is suspected to be resulting from the wear and tear that occurs during insertion and removal.·301-30-018 - the 3.0mm x 12mm non-locking screw is failing for feature 13 (verify hexalobe).The hexalobe damage is suspected to be resulting from the wear and tear that occurs during insertion and removal.·302-30-016 - the 3.0mm x 16mm locking screw is failing for feature 11 (minor hexalobe diameter), feature 12 (major hexalobe diameter), and feature 15 (verify hexalobe).Additionally, due to thread damage, the oasis vision system features could not be captured.The hexalobe damage and thread damage is suspected to be resulting from the wear and tear that occurs during insertion and removal as well as from being locked in the plate for ~3 years.The thread damage may also be a result of the plate breakage.·302-30-018 - the 3.0mm x 18mm locking screw is failing for feature 11 (minor hexalobe diameter), feature 12 (major hexalobe diameter), and feature 15 (verify hexalobe).Additionally, due to thread damage, the oasis vision system features could not be captured.The hexalobe damage and thread damage is suspected to be resulting from the wear and tear that occurs during insertion and removal as well as from being locked in the plate for ~3 years.The thread damage may also be a result of the plate breakage.·302-30-020 - the 3.0mm x 20mm locking screw is failing for feature 11 (minor hexalobe diameter), feature 12 (major hexalobe diameter), and feature 15 (verify hexalobe).Additionally, due to thread damage, the oasis vision system features could not be captured.The hexalobe damage and thread damage is suspected to be resulting from the wear and tear that occurs during insertion and removal as well as from being locked in the plate for ~3 years.The thread damage may also be a result of the plate breakage.·300-52-005 - the petite mpj plate was failing for feature 1 (overall length), feature 14-1 (land width), feature 14-2 (verify clover leaf), feature 14-3 (verify complete thread), feature 14-4 (verify locking hole), and feature 14-5 (verify presence of land and no break through).These features were failing due to the breakage occurring across the specific hole being inspected for feature 14.Additionally, the vision system features could not be inspected due to the breakage.The petite mpj plate was also failing for feature 16 (plate thickness), feature 17 (plate thickness), feature 23 (plate thickness), feature 24 (plate thickness), feature 27 (compression hole depth), and feature 28 (distance to laser marked line).The petite mpj plate was manufactured, inspected, and released in 2017 under revision c.These features were failing due to an update that occurred within revision e to increase the plate thickness as well as add the gauge check for the compression hole.Simulated use testing.Simulated use testing was not conducted for the returned device(s) nor with similar parts.Due to the nature of the event (hardware breakage after ~3 years of implantation), simulated use testing would not be able to adequately recreate the reported event.Thus, simulated use testing was not performed.Investigation conclusion.The similar complaints identified did not provide further assistance in the evaluation of the root cause for the reported event.There were no abnormalities to document in regards to the dhr review.There was no reported patient noncompliance.As documented on the associated customer complaint report (ccr) information and evaluation, frm qlt-005h, the hardware was implanted ~3 years prior to the removal.In the "review of surgical technique" section above, it was discussed that the gridlock plating system is intended for temporary fixation only until osteogenesis occurs.It is to be noted that the plate was implanted for approximately 16 times longer than the average time to union (~66 days).However, it is not expected that the device failure is attributed to the implantation time as supported with the following justification: the gridlock plate (pn: 300-52-005, lot #: tsl004803) was made from commercially pure titanium (astm f67).According to device lifetime report titanium based fixation devices.Mat-0001 revision 0, commercially pure titanium (astm f67) is expected to survive in the small bones of the human body for at least 15 years.However, it is to be noted that "the implant is minimally loaded as the healed bone bears the load, and the survivability of the device becomes primarily a biological issue" following 3 to 4 months after surgery.Under the investigation into the biological response of commercially pure titanium (astm f67), it is documented that "hardware can be overloaded and fail.The likelihood of this is low unless a severe trauma event is experienced." there was no report of a severe trauma event directed at the surgical site in this instance.Thus, the device failure cannot be confirmed to be attributed to a severe trauma event.The root cause remains unknown.
Event or Problem Description
On 01/29/2021, a trilliant surgical independent sales representative emailed a trilliant surgical sales support specialist to report of a plate removal that occurred on (b)(4) 2021 with doctor 1 at facility 1.Previously, doctor 1 had implanted the 300-52-005 (petite mpj plate, left) plate construct roughly 3 years ago (exact date remains unknown at this point in the investigation) on a (b)(6) year-old female patient at facility 1.The sales representative stated that the patient came in reporting pain at the surgical site on 2021.(b)(6) upon review, it was seen that the plate had broken in half which was causing the local irritation at the surgical site.Doctor 1 removed the plate, associated screws (sizes to be determined upon receipt of parts), and any additional debris associated with the break from the site and stated that "pseudo-fusion" had occurred.Doctor 1 was satisfied with the fusion result and left the site as-is after the removal.The broken 300-52-005 and associated gridlock screws are expected to be returned to corporate for further review.

• Brand Name: PETITE MPJ PLATE, LEFT
• Common Device Name: GRIDLOCK PLATING SYSTEM PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 north shepherd drive; suite 100; houston TX 77007 1320
• MDR Report Key: 11388726
• Report Number: 3007420745-2021-00006
• Device Sequence Number: 2190796
• Product Code: HRS
• UDI-Device Identifier: 00812926025360
• UDI-Public: (01)00812926025360(10)TSL004803
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/26/2021

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: 300-52-005
• Device Lot Number: TSL004803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/26/2021
• 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: 61 YR