MAUDE Adverse Event Report: TRILLIANT SURGICAL 5.5 X 30MM STTHCS; TIGER LARGE HEADLESS CANNULATED SCREW SYSTEM SCREW

Model Number 207-55-030

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem Discomfort (2330)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

Investigation summary: an event was reported on 08/23/2019 where a 207-55-030 tlchs was causing pain due to patient noncompliance.The screw was removed on (b)(6) 2019.The screw was originally implanted on (b)(6) 2019 with no reported issues during the initial implantation.The screw was returned to corporate and an investigation was completed.Dhr review: the returned screw was laser mark identified as from lot tsl004287.The dhr for lot ts004287 was reviewed.This lot released 60 parts of 207-55-030 at revision a on (b)(6) 2019.100% of parts were inspected at quality final inspection with no material nonconformances noted.There were no deviations or reworks associated with this lot.The dhr review did not identify any discrepancies.Visual/dimensional review: the returned part was visually reviewed to determine any obvious issues related to the event.The screw was visually observed to be in good condition; no obvious damage was observed and the threads were still sharp even after insertion and removal.The screw was dimensionally inspected to rev a, which it was manufactured.Current revision (rev d) vision systems were used to complete the inspection but these features were confirmed to be identical to the rev a specifications.The screw was confirmed to be in specification for all features.Simulated use testing: simulated use testing was not completed as there are no relevant internal testing that could simulate causing pain while inserted.Previous complaints review the complaints log was reviewed and this is the only complaint ever received in the 207-55-xxx family.Root cause analysis: the investigation did not identify any issues related to the dhr, to the visual or dimensional quality of the screw, or any systemic issues with previous complaints.The most likely root cause of the tiger headless cannulated screw becoming painful is due to patient noncompliance, as stated in the event description.Fusion did begin to occur, and the surgeon did not feel a need to re-fixture the site after the removal.

Event Description

On 08/23/2019 our trilliant sales representative reported the surgeon reached out to him on 08/21/2019 to notify him of an upcoming removal case for a recently implanted 207-55-030 (5.5 x 30 mm stthcs).The surgeon reported that due to patient noncompliance through early ambulation the head of the headless large cannulated screw had broken through the distal cortex of the great toe and was rubbing on the nail causing patient discomfort.The 207-55-030 was originally implanted on (b)(6) 2019 by the surgeon at (b)(6) during an interphalangeal joint fusion of the great toe (ipj fusion) on a (b)(6) female patient.The rep's personal inventory was utilized in the case and invoiced out accordingly with no reported issues.The surgeon reported this case went as planned.The 207-55-030 was successfully removed on (b)(6) 2019 at (b)(6) by the surgeon.The screw was not replaced after removal, the surgeon confirmed union was already occurring and did not feel the need to fixate any further.The sales representative returned the 207-55-030 (5.5 x 30 mm stthcs) to trilliant in person on (b)(6) 2019.

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 1-8 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 when the head of the screw broke through the distal cortex.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.Reprocessor name and address (d9) n/a to this report.6.Concomitant medical products and therapy dates (d11) not reported.7.Section h9 n/a to this report.8.No files attached to this report.

Event Description

On (b)(6) 2019, a trilliant surgical sales representative reported a surgeon reached out to him on (b)(6)2019 to notify him of an upcoming removal case for a recently implanted 5.5 x 30mm stthcs (207-55-030).The surgeon reported that, due to patient noncompliance through early ambulation, the head of the headless large cannulated screw had broken through the distal cortex of the great toe and was rubbing on the nail causing patient discomfort.The 207-55-030 was originally implanted on (b)(6)2019 by the surgeon at facility x during an interphalangeal joint fusion (ipj fusion) of the great toe on a 29-year-old female patient.The sales representative's personal inventory was utilized in the case and invoiced out accordingly with no reported issues.The surgeon reported this case went as planned.The 207-55-030 was successfully removed on (b)(6)2019 at facility x by the surgeon.The screw was not replaced after removal as the surgeon confirmed union was already occurring and did not feel the need to fixate any further.The sales representative returned the 5.5 x 30mm stthcs (207-55-030) to trilliant surgical in-person on (b)(6)2019.

• Brand Name: 5.5 X 30MM STTHCS
• Type of Device: TIGER LARGE HEADLESS CANNULATED SCREW SYSTEM SCREW
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n shepherd dr; ste 100; houston TX 77007
• MDR Report Key: 9076303
• MDR Text Key: 163122039
• Report Number: 3007420745-2019-00041
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K153338
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 207-55-030
• Device Catalogue Number: 207-55-030
• Device Lot Number: TSL004287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Distributor Facility Aware Date: 08/23/2019
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR