MAUDE Adverse Event Report: TRILLIANT SURGICAL 2.4MM X 28MM TIGER CANNULATED SCREW; TIGER CANNULATED SCREW SYSTEM SCREW

Model Number 200-24-028

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Event description: a 200-24-028 tiger screw was removed due to patient pain.The screw was previously inserted as a part the mib plating system on (b)(6) 2019 and was removed on (b)(6) 2019.Review of surgical technique: the complaints log was reviewed during (b)(6) of 2019 to determine if issues were reported during the initial implantation.Ccr (b)(4) was identified as highly likely the same patient, as it is related to an mib plate implanted on (b)(6) 2019 with a (b)(6) female patient.This cccr was reviewed.During implantation, the surgeon experienced difficulty inserting the third screw into the mib plate, and had to insert a shorter screw.The surgeon stated that he was satisfied with the compression and did not have further issues.The screw which was removed, is the "lag" screw (per the event description) or the interfrag screw, which is the 4th (last) screw placed into the mib plate.As the surgeon was satisfied with the plate compression and did not have any further issues, the event associated with ccr (b)(4) is considered unrelated to the event.Dhr review: the lot number for both the 200-24-028 tiger cannulated screw and 300-70-001 mib plate implanted could not be definitively determined as it was used from a set with multiple other screws from different lots.The lot number cannot be entirely confirmed, as the part was not returned and remains implanted in the patient.Using the netssuit erp system he potential lot numbers were determined by generating a historical record of parts utilized from mib loaner #2.The potential lots for the 200-24-028 screw are lots: tsl005906, tsl005037, tsl006012, tsl006323.These dhr's were reviewed for any nonconformances, deviations, reworks, and completeness of the traveler, at a minimum.No issues were identified related to the event in any of the dhr's.The lot number for the 300-70-001 mib plate was determined to most likely be from lot tsl006447.The dhr for lot tsl006447 was reviewed and there were no nonconformances, deviations, or reworks.The traveler is complete and parts were inspected 100% for all critical features.Visual / dimensional inspection: parts were not returned and a visual/dimensional inspection cannot be performed.Simulated use testing: parts were not returned and a simulated inspection cannot be performed due to the nature of the complaint.Evaluation of similar complaints: (b)(4), customer complaint report log, was reviewed for similar events involving the mib plating system.Multiple similar complaints were identified through identification and review of capa (b)(4): (b)(4).This was the only report identified during 2018 or 2019 involved with this surgeon or sales representative.In response to several complaints received, capa (b)(4) was initiated on 03/26/19 to determine if any necessary corrective actions were required due to reported mib hardware removals.All listed complaints had an unknown root cause as a result of limited information available or parts not being returned.Reference capa (b)(4) for more information.The ifu was revised as a part of capa (b)(4), effective on 07/01/19.The mib plate associated with this complaint was implanted on 04/16/19 and is considered within the scope of the capa as the other reported events also involved tiger cannulated screws backing out leading to hardware removal.Summary / root cause analysis: due to the parts not being returned and lot numbers being unknown, a limited investigation was completed.Through review of the case details, previous complaint history and root cause analysis of capa (b)(4), a suspected root cause is that correct screw length may not have been utilized for the tiger cannulated screws, however, this cannot be confirmed as only limited information was available for investigation.The root cause is considered unknown at this time, and the field shall continue to be monitored for need of additional action.

Event Description

On (b)(6) 2019, (b)(6) emailed in to sales support with a text message thread from dr.(b)(6) stating that a patient was reporting of pain from the lag screw from a previous procedure utilizing the mib plating system.Dr.(b)(6) scheduled a removal to occur on (b)(6) 2019 to remove the tiger cannulated screw from the surgical site.The original implantation occurred on (b)(6) 2019 at (b)(6) on a (b)(6) female patient.The lag screw (to be later removed) was a 200-24-028 (2.4 x 28mm tiger cannulated screw) utilized from minimally invasive bunion plating system loaner #2, which was previously provided from corporate for the aforementioned case.(b)(6) will be present at the removal case and shall provide any ancillary details about the removal and return the 200-24-028 for further review.On (b)(4) 2019, (b)(6), followed up with (b)(6) about the aforementioned removal.The removal took place on (b)(6) 2019 in dr.(b)(6) office.(b)(6) stated that dr.(b)(6) texted him after the removal that " the screw came out no problem and that by inserting a new k-wire he achieved the desired angle for correction." (b)(6) will be meeting with dr.(b)(6) on (b)(6) 2019 and will attempt to retrieve the 200-24-028 and return back to corporate for further review.On 12/12/19, the part was confirmed to have not been returned after multiple attempts to contact the representative.A re-training memo was sent to the representative as all parts associated with a complaint should be returned, when possible.

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 date of birth (a2) and weight (a4) not reported.2.Date of event (b3) is unknown.The event is considered to be the onset of patient pain.3.Catalog # and serial # (d4) not utilized by trilliant surgical.4.Expiration date (d4) is n/a to non-sterile trilliant surgical products.5.As described in section h10 of the initial submission, lot # (d4) could not be definitively determined.All possibilities for lot # and unique identifer (udi) # 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.See possibilities below.9.Section h9 n/a to this report.10.No files attached to this report.Lot #, udi, and manufacturing date information (omitted from initial submission) 2.4mm x 28mm tiger cannulated screw (200-24-028).1.Lot tsl005906 - udi (b)(4), manufactured 02/06/2018.2.Lot tsl005037 - udi (b)(4),manufactured 06/13/2017.3.Lot tsl006012 - udi (b)(4), manufactured 03/21/2018.4.Lot tsl006323 - udi (b)(4),manufactured 07/17/2018.Minimally invasive bunion plate, right (300-70-001).1.Tsl006447 - udi (b)(4), manufactured 08/15/2018.

Event Description

On (b)(6) 2019, a trilliant surgical sales representative emailed in to trilliant surgical sales support with a text message thread from doctor 1 stating that a patient was reporting of pain from the lag screw from a previous procedure utilizing the minimally invasive bunion (mib) plating system.Doctor 1 scheduled a removal to occur on (b)(6) 2019 to remove the tiger cannulated screw from the surgical site.The original implantation occurred on (b)(6) 2019 at facility x on a 64-year-old female patient.The lag screw (to be later removed) was a 2.4mm x 28mm tiger cannulated screw (200-24-028) utilized from minimally invasive bunion plating system loaner #2, which was previously provided from corporate for the aforementioned case.The sales representative will be present at the removal case and shall provide any ancillary details about the removal and return the 200-24-028 for further review.On (b)(6) 2019, sales support followed up with the sales representative about the aforementioned removal.The removal took place on (b)(6) 2019 in doctor 1's office.The sales representative stated that doctor 1 texted him after the removal that "the screw came out no problem and that by inserting a new k-wire he achieved the desired angle for correction".The sales representative will be meeting with doctor 1 on (b)(6) 2019 and will attempt to retrieve the 200-24-028 and return back to corporate for further review.On (b)(6) 2019, it was confirmed that parts were not returned.A re-training memo was sent to the sales representative.

• Brand Name: 2.4MM X 28MM TIGER CANNULATED SCREW
• Type of Device: TIGER CANNULATED SCREW SYSTEM SCREW
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n shepherd dr; ste 100; houston TX 77007
• MDR Report Key: 9462666
• MDR Text Key: 185934757
• Report Number: 3007420745-2019-00051
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00812926020815
• UDI-Public: 00812926020815
• Combination Product (y/n): N
• PMA/PMN Number: K172178
• 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: 11/14/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 200-24-028
• Device Lot Number: SEE NARRATIVE
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/14/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• 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
• Patient Age: 64 YR