MAUDE Adverse Event Report: TRILLIANT SURGICAL 3.0 X 32MM TIGER CANN. HEADLESS SCREW; TIGER HEADLESS CANNULATED SCREW SYSTEM SCREW

Model Number 202-30-032

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned to trilliant for evaluation.The lot number was unknown.A dhr review, dimensional/visual/simulated use testing were not able to be completed.The complaints log was reviewed and only one similar event was identified in the past 12 months.The field shall continue to be monitored.

Event Description

Dr.(b)(6) performed a bunionectomy on a (b)(6) female patient with average bone quality on (b)(6) 2019 at (b)(6).The 202-30-032 3.0 x 32mm tiger cannulated headless screw was removed on (b)(6) 2019.The reason for removal is unknown but (b)(4), our trilliant sales representative, believes it was because of painful hardware.The 202-30-032 screw was discarded at the removal case.

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 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.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.Corrected information provided in follow-up submission.B5 - description of event/problem for initial submission - corrected to not identify any physician or institution by name.D2 - common device name corrected (product code was correct in initial submission).D3 - fax number added.D4 - catalog #, serial #.E1 - initial reporter corrected to be the physician who reported the event to the sales representative.The sales representative's email address is deleted.Section f is n/a to this report.G1, g2 - fax number added.G3 - health professional and distributor are selected, company representative is deleted.H6 - method codes 4115, 4111, and 3331 added.H10 - corrected data - investigation summary typos from initial submission are corrected below.Additional information provided in follow-up submission: d4 - lot #, unique identifier (udi) #.G1 - name, telephone, and email address updated as different personnel is submitting the follow-up submission than submitted the initial submission.H10 - additional manufacturer narrative investigation summary the product was not returned to trilliant surgical for evaluation.The lot number was unknown as of 12/07/2019.Dimensional/visual/simulated use testing were not able to be completed.Frm qlt-005c, customer complaint report log, was reviewed for the past year for removal cases involved with 202-xx-xxx screws and one (1) complaint was identified where a 202-30-0xx screw was removed due to pain.This complaint did not have parts returned and a root cause was not determined.The field shall continue to be monitored.This investigation did not isolate a root cause of the event for painful hardware.Additional investigation conducted 03/23/2020: lot 75gb0233 was identified for this event.The corresponding device history record (dhr) was reviewed for any significant events (i.E.Nonconformances, reworks, deviations) that may correlate to the reported event.No adverse events were identified.As a result of the dhr review, it is concluded that there are no identified issues correlating to the reported event.

Event Description

Doctor 1 performed a bunionectomy on a 43-year-old female patient with average bone quality on (b)(6) 2019 at facility x.The 3.0 x 32mm tiger cann.Headless screw (202-30-032) was removed on (b)(6) 2019.The reason for removal is unknown, but the associated trilliant surgical sales representative believes it was because of painful hardware.The 202-30-032 was discarded at the removal case.This event was initially reported on (b)(6) 2019, but details such as patient information were provided/confirmed by the sales representative on 11/14/2019 and received by trilliant surgical sales support.

• Brand Name: 3.0 X 32MM TIGER CANN. HEADLESS SCREW
• Type of Device: TIGER HEADLESS CANNULATED SCREW SYSTEM SCREW
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n shepherd dr; ste 100; houston TX 77007
• MDR Report Key: 9434834
• MDR Text Key: 181373982
• Report Number: 3007420745-2019-00049
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K112737
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 202-30-032
• Device Catalogue Number: 202-30-032
• Device Lot Number: 75GB0233
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/08/2019
• Event Location: Hospital
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR